FrancophonIA/ELRC3.0 huggingface dataset:
English: The improvements in PFS and OS in favour of patients receiving IMFINZI compared to those receiving placebo were consistently observed in all predefined subgroups analysed, including ethnicity, age, gender, smoking history, EGFR mutation status and histology.
Maltese: It-titjib fil-PFS u fl-OS favur pazjent li rċivew IMFINZI meta mqabbel ma' dawk li rċivew il-plaċebo ġew osservati b'mod konsistenti fis-sottogruppi definiti minn qabel kollha li ġew analizzati, inkluż letniċità, l-età, is-sess, storja ta' tipjip, status tal-mutazzjoni EGFR u istoloġija.
English: In patients treated with durvalumab in the PACIFIC Study, the proportion of patients who experienced a laboratory abnormality worsening from baseline was as follows: 38.5% (all Grades), 2.3% (Grades 3-4) for alanine aminotransferase increased, 36.0% (all Grades), 2.8% (Grade 3-4) for aspartate aminotransferase increased, 16.3% (all Grades) for creatinine increased, 26.5% (all Grades) for TSH elevated > ULN and above baseline, 31.9% (all Grades) for TSH decreased < LLN and below baseline.
Maltese: 38.5 % (il-Gradi kollha) 2.3 % (Gradi 3-4) għal żieda fl-alanina aminotransferażi, 36.0 % (il-Gradi kollha) 2.8 % (Grad 3-4) għal żieda flaspartataminotransferażi, 16.3 % (il-Gradi kollha) għal żieda fil-kreatinina, 26.5 % (il-Gradi kollha) għal żieda fit-TSH >ULN u aktar mil-linja bażi, 31.9 % (il-Gradi kollha) għal tnaqqis fit-TSH > LLN u inqas mil-linja bażi.
English: 10 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a white flip-off aluminium seal containing 500 mg durvalumab.
Maltese: 10 ml ta' konċentrat f'kunjett tal-ħġieġ tat-Tip 1 b'tapp elastomeriku u siġill tal-aluminju abjad tat-tip flip off li fih 500 mg durvalumab.
English: At baseline, no differences in patient reported symptoms, function and HRQoL were observed between IMFINZI and placebo groups.
Maltese: Fil-linja bażi, ma ġiet osservata l-ebda differenza fis-sintomi, funzjoni u HRQoL irrappurtati millpazjenti bejn il-gruppi ta' IMFINZI u plaċebo.
English: • underactive function of pituitary gland (hypopituitarism including diabetes insipidus) that can cause tiredness, an increase in the amount of your urine
Maltese: • funzjoni mhux attiva biżżejjed tal-glandola pitwitarja (ipopitwitariżmu inkluż dijabete insipidus) li tista' tikkawża għeja, żieda fl-ammont tal-awrina tiegħi
English: d includes gingivitis, oral infection, periodontitis, pulpitis dental, tooth abscess and tooth infection.
Maltese: d tinkludi ġinġivite, infezzjoni fil-ħalq, perjodontite, pulpite dentali, axxess fis-snien u infezzjoni fis-snien.
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients.
Maltese: Ma ġiet irrapportata ebda differenza ġenerali bejn pazjenti anzjani (≥65 sena) u pazjenti iżgħar fl-età.
English: Number of patients at risk
Maltese: Numru ta' pazjenti f'riskju
English: The median time to onset was 53 days (range: 1-341 days).
Maltese: Iż-żmien medjan għall-bidu kien ta' 53 jum (medda: 1-341 jum).
English: Since the primary elimination pathways of durvalumab are protein catabolism via reticuloendothelial system or target-mediated disposition, no metabolic drug-drug interactions are expected.
Maltese: Peress li l-passaġġi ta' eliminazzjoni primarji ta' durvalumab huma kataboliżmu tal-proteina permezz ta' sistema retikuloendoteljati jew dispożizzjoni medjata mill-mira, mhi mistennija l-ebda interazzjoni mediċinali metabolika.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hepatitis occurred in 19 (1.0%) patients, including Grade 3 in 11 (0.6%) patients and Grade 5 (fatal) in 1 (< 0.1%) patient.
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, epatite medjata mis-sistema immuni seħħet fi 19 (1.0%)-il pazjent, inkluż Grad 3 fi 11 (0.6%)-il pazjent u Grad 5 (fatali) f'pazjent 1 (< 0.1%).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with durvalumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use).
Maltese: L Aġenzija Ewropea għall Mediċini iddifferiet l obbligu li jiġu ppreżentati riżultati tal istudji b'durvalumab fis-subsettijiet kollha tal popolazzjoni pedjatrika fil kura ta' neoplażmi malinni (ħlief tumuri fis-sistema nervuża ċentrali, neoplażmi emopojetiċi u tat-tessut tal-limfojde) (ara sezzjoni 4.2 għal informazzjoni dwar l użu pedjatriku).
English: • abnormal kidney function tests (blood creatinine increased)
Maltese: • testijiet anormali tal-funzjoni tal-kliewi (żieda fil-kreatinina fid-demm)
English: The overall incidence of Grade 3 or 4 adverse reactions was 12.8% in the IMFINZI arm vs 9.8% in placebo.
Maltese: L-inċidenza ġenerali ta' reazzjonijiet avversi ta' Grad 3 jew 4 kienet 12.8% fil-fergħa ta' IMFINZI vs 9.8% fi plaċebo.
English: Initiate thyroid hormone replacement as clinically indicated
Maltese: Ibda sostituzzjoni talormon tat-tirojde kif indikat klinikament
English: The recommended dose is 10 mg of durvalumab per kilogram of your body weight.
Maltese: Id-doża rakkomandata hija 10 mg ta' durvalumab għal kull kilogramma tal-piż tal-ġisem tiegħek.
English: The study demonstrated a statistically significant improvement in OS in the IMFINZI-treated group compared with the placebo group [HR = 0.68 (95% CI: 0.53, 0.87), p = 0.00251].
Maltese: L-istudju wera titjib statistikament sinifikanti fl-OS fil-grupp ikkurat b'IMFINZI meta mqabbel mal-grupp tal-plaċebo [HR = 0.68 (95% CI: 0.53, 0.87), p = 0.00251]. Ara t-Tabella 4 u l-Figuri 1 u 2.
English: PD-L1 testing for patients with locally advanced NSCLC Patients with locally advanced NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test (section 5.1).
Maltese: Ittestjar PD-L1 għal pazjenti b'NSCLC avvanzat lokalment Pazjenti b'NSCLC avvanzat lokalment għandhom jiġu evalwati għal kura abbażi tal-espressjoni tattumur PD-L1 ikkonfermat b'test ivvalidat (sezzjoni 5.1).
English: Patients should be monitored for clinical signs and symptoms of adrenal insufficiency.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' insuffiċjenza adrenali.
English: Dental and oral soft tissue infections
Maltese: Infezzjonijiet fis-snien u fit-tessut artab
English: Twenty-six of the 34 patients received medical therapy (thiamazole, carbimazole, propylthiouracil or beta-blocker), 12 patients received thyroxine when hyperthyroidism transitioned to hypothyroidism, 12 patients received systemic corticosteroids and 3 of the 12 patients received high-dose systemic corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Maltese: Sitta u għoxrin mill-34 pazjent irċivew terapija medika (thiamazole, carbimazole, propylthiouracil, jew betablocker), 12-il pazjent irċivew thyroxine meta lipertirojdiżmu qeleb għal ipotirojdiżmu, 12-il pazjent irċivew kortikosterojdi sistemiċi u 3 mit-12il pazjent irċivew kura b'kortikosterojdi sistemiċi ta' doża għolja (tal-inqas 40 mg prednisone jew ekwivalenti kuljum).
English: The median time to onset was 85 days (range: 9-378 days).
Maltese: Iż-żmien medjan għall-bidu kien ta' 85 jum (medda: 9378 jum).
English: • serious lung infections (pneumonia)
Maltese: • infezzjonijiet serji tal-pulmun (pnewmonja)
English: Infections and infestations Upper respiratory tract infections
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjonijiet fil-parti ta' fuq talapparat respiratorju
English: Throughout the duration of the study to Week 48, there was no clinically meaningful difference between IMFINZI and placebo groups in symptoms, functioning and HRQoL (as assessed by a difference of greater than or equal to 10 points).
Maltese: Matul id-durata tal-istudju sa Ġimgħa 48, ma kien hemm l-ebda differenza klinikament sinifikanti bejn il-gruppi ta' IMFINZI u plaċebo fis-sintomi, filfunzjonament u f'HRQoL (kif ivvalutati permezz ta' differenza ta' aktar minn jew daqs 10 punti).
English: Each vial contains either 500 mg of durvalumab in 10 mL of concentrate or 120 mg of durvalumab in 2.4 mL of concentrate.
Maltese: Kull kunjett fih jew 500 mg ta' durvalumab f'10 mL ta' konċentrat jew 120 mg ta' durvalumab f'2.4 mL ta' konċentrat.
English: In the IMFINZI-treated group, 44 of the 51 patients received systemic corticosteroids, including 28 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
Maltese: Fil-grupp ikkurat b'IMFINZI, 44 mill-51 pazjent irċivew kortikosterojdi sistemiċi, inkluż 28 pazjent li rċivew kura b'kortikosterojdi ta' doża għolja (tal-inqas 40 mg prednisone jew ekwivalenti kuljum), u 2 pazjenti rċivew ukoll infliximab.
English: The median time to onset in the IMFINZI-treated group was 53 days (range: 1-341 days) vs. 55.5 days (range: 0-231 days) in the placebo group.
Maltese: Iż-żmien medjan għall-bidu fil-grupp ikkurati b'IMFINZI kien ta' 53 jum (medda: 1341 jum) kontra 55.5 jiem (medda: 0231 jum) fil-grupp ikkurat bil-plaċebo.
English: Hazard ratio (95% CI):
Maltese: Proporzjon ta' periklu (95% CI):
English: Adverse drug reactions are listed according to system organ class in MedDRA.
Maltese: Ir-reazzjonijiet avversi għal mediċina huma elenkati skont is-sistema tal-klassifika tal-organi f'MedDRA.
English: In the placebo group, 11 of the 16 patients received systemic corticosteroids, including 9 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Maltese: Fil-grupp tal-plaċebo, 11 mis-16-il pazjent irċivew kortikosterojdi sistemiċi, inkluż 9 pazjenti li rċivew kura b'kortikosterojdi ta' doża għolja (tal-inqas 40 mg prednisone jew ekwivalenti kuljum).
English: When you get IMFINZI, you can have some serious side effects (see section 2).
Maltese: Meta tieħu IMFINZI, jista' jkollok xi effetti sekondarji serji (ara sezzjoni 2).
English: The time to onset was 42 days.
Maltese: Ir-riżoluzzjoni seħħet fi 42 pazjent.
English: OS Number of deaths (%) Median (months) (95% CI)
Maltese: Numru ta' mwiet (%) Medjana (xhur) (95% CI)
English: Two (0.1%) patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Maltese: Żewġ (0.1%) pazjenti rċivew kura b'kortikosterojdi ta' doża għolja (tal-inqas 40 mg prednisone jew ekwivalenti kuljum).
English: All 7 patients received systemic corticosteroids; 2 of the 7 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Maltese: Is-7 pazjenti kollha rċivew kortikosterojdi sistemiċi; 2 mis-7 pazjenti rċivew kura b'kortikosterojdi ta' doża għolja (tal-inqas 40 mg prednisone jew ekwivalenti kuljum).
English: Grade 3 with AST or ALT > 5-≤ 8 x ULN or total bilirubin > 3≤ 5x ULN Grade 3 with AST or ALT > 8 x ULN or total bilirubin > 5 x ULN
Maltese: Grad 3 b'AST jew ALT >5-≥8 x ULN jew bilirubina totali >3-≥5 x ULN
English: Common Injury, poisoning and procedural complications Infusion related reaction
Maltese: Komuni Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Reazzjoni relatata mal-infużjoni
English: Immune-mediated adrenal insufficiency occurred in patients receiving IMFINZI (see section 4.8).
Maltese: Seħħet insuffiċjenza adrenali medjata mis-sistema immuni f'pazjenti li rċivew IMFINZI (ara sezzjoni 4.8).
English: The primary elimination pathways of durvalumab are protein catabolism via reticuloendothelial system or target mediated disposition.
Maltese: Il-passaġġi ta' eliminazzjoni primarji ta' durvalumab huma kataboliżmu tal-proteini mis-sistema retikuloendoteljati jew dispożizzjoni medjata mill-mira.
English: Data from patients with moderate and severe hepatic impairment are limited.
Maltese: Dejta minn pazjenti b'indeboliment tal-fwied moderat u sever hija limitata.
English: • Do not shake the vial.
Maltese: • kellek trapjant ta' organu;
English: Withold dose
Maltese: Issospendi d-doża
English: Children and adolescents IMFINZI should not be used in children and adolescents below 18 years of age.
Maltese: Tfal u adolexxenti IMFINZI m'għandux jintuża fi tfal u adolexxenti taħt l-età ta' 18-il sena.
English: e includes autoimmune hypothyroidism and hypothyroidism.
Maltese: e tinkludi ipotirojdiżmu u ipertirojdiżmu awtoimmuni.
English: • flu
Maltese: • influwenza
English: The median time to onset was 70 days (range: 15-312 days).
Maltese: Iż-żmien medjan għall-bidu kien ta' 70 jum (medda: 15312-il jum).
English: • a condition leading to high blood sugar levels (type 1 diabetes mellitus)
Maltese: • kundizzjoni li twassal għal livelli għoljin ta' zokkor fid-demm (diabetes mellitus ta' tip 1)
English: PFS
Maltese: PC:
English: In the combined safety database with IMFINZI monotherapy, immune-mediated colitis or diarrhoea occurred in 31 (1.6%) patients, including Grade 3 in 6 (0.3%) patients and Grade 4 in 1 (<0.1%) patient.
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, kolite jew dijarea medjata missistema immuni seħħet f'31 (1.6%) pazjent, inkluż Grad 3 f'6 (0.3%) pazjenti u Grad 4 f'pazjent 1 (< 0.1%).
English: In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery, at exposure levels approximately 18 times higher than those observed at the clinical dose of 10 mg/kg of durvalumab (based on AUC), was associated with placental transfer but not with maternal toxicity or effects on embryofoetal development, pregnancy outcome or postnatal development.
Maltese: Fi studji dwar riproduzzjoni ta' annimali, l-għoti ta' durvalumab lil xadini cynomolgus tqal mill-konferma ta' tqala permezz tal-għoti, f'livelli tal-esponiment madwar 18-il darba ogħla min dawk osservati bid-doża klinika ta' 10 mg/kg ta' durvalumab (abbażi tal-AUC), ġie assoċjat ma' trasferiment tal-plaċenta iżda mhux ma' tossiċità materna jew effetti fuq l-iżvilupp tal-embrijun jew tal-fetu, riżultat tat-tqala jew żvilupp wara t-twelid.
English: Permanently discontinue IMFINZI if adverse reaction does not resolve to ≤ Grade 1 within 30 days or if there are signs of respiratory insufficiency.
Maltese: Waqqaf IMFINZI b'mod permanenti jekk ir-reazzjoni avversa ma tiġix għal ≤ Grad 1 fi żmien 30 jum jew jekk ikun hemm sinjali ta' insuffiċjenza respiratorja.
English: Based on population PK analysis that included 1878 patients in the dose range of ≥ 10 mg/kg every 2 weeks, the geometric mean steady state volume of distribution (Vss) was 5.64 L. Durvalumab clearance (CL) decreased over time resulting in a geometric mean steady state clearance (CLss) of 8.16 mL/h at Day 365; the decrease in CLss was not considered clinically relevant.
Maltese: Abbażi tal-analiżi tal-PK tal-popolazzjoni li inkludiet 1878 pazjent fil-medda tad-doża ta' ≤10 mg/kg kull ġimagħtejn, ilvolum ta' distribuzzjoni fl-istat fiss (Vss) medju ġeometriku kien 5.64 L.
English: Additional subgroup analyses were conducted to evaluate the efficacy by tumour PD-L1 expression (≥ 25%, 1-24%, ≥ 1%, < 1%) and for patients whose PD-L1 status cannot be established (PD-L1 unknown).
Maltese: Saru analiżijiet tas-subgrupp addizzjoni biex tiġi evalwata l-effikaċja skont l-espressjoni PD-L1 tattumur (≥ 25%, 1-24%, ≥ 1%, < 1%) u għal pazjenti li l-istatus PD-L1 tagħhom ma jistax jiġi stabbilit (PD-L1 mhux magħruf).
English: Concurrent ALT or AST > 3 x ULN and total bilirubin > 2 x ULN with no other cause
Maltese: ALT jew AST >3 x ULN konkurrenti u bilirubina totali >2 x ULN b'ebda kawża oħra
English: • hoarse voice (dysphonia)
Maltese: • vuċi maħnuqa (disfonija)
English: In the combined safety database with IMFINZI monotherapy, immune-mediated adrenal insufficiency occurred in 7 (0.4%) patients, including Grade 3 in 1 (< 0.1%) patient.
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, insuffiċjenza adrenali medjata mis-sistema immuni seħħet f'7 (0.4%) pazjenti, inkluż Grad 3 f'pazjent 1 (< 0.1%).
English: Grade 3 or 4, or any Grade with positive biopsy
Maltese: Grad 3 jew 4, jew kwalunkwe Grad b'bijopsija pożittiva
English: • Visually inspect the medicinal product for particulate matter and discolouration.
Maltese: • Spezzjoni l-prodott mediċinali viżwalment għal xi partikuli u skulurament.
English: One vial of 2.4 ml of concentrate contains 120 mg of durvalumab.
Maltese: Kunjett wieħed ta' 2.4 ml tal-konċentrat fih 120 mg ta' durvalumab.
English: Severe infusion related reactions have been reported in patients receiving IMFINZI (see section 4.8).
Maltese: Ġew irrappurtati diversi reazzjonijiet relatati mal-infużjoni f'pazjenti li rċivew IMFINZI (ara sezzjoni 4.8).
English: The two primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) of IMFINZI vs. placebo.
Maltese: Iż-żewġ end-points koprimarji tal-istudju kienu sopravivenza mingħajr progressjoni (PFS) u sopravivenza globali (OS) ta' IMFINZI kontra plaċebo.
English: Withold dose until clinically stable
Maltese: Waqqaf id-doża sakemm klinikament stabbli
English: In the combined safety database with IMFINZI monotherapy, infusion related reactions occurred in 35 (1.9%) patients, including Grade 3 in 5 (0.3%) patients.
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, reazzjonijiet relatati mal-infużjoni seħħew f'35 (1.9%) pazjent, inkluż Grad 3 f'5 (0.3%) pazjenti.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hypothyroidism occurred in 137 (7.3%) patients, including Grade 3 in 1 (< 0.1%) patient.
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, ipotirojdiżmu medjat mis-sistema immuni seħħ f'137 (7.3%) pazjent, inkluż Grad 3 fi pazjent 1 (< 0.1%).
English: Patients should be monitored for clinical signs and symptoms of type 1 diabetes mellitus.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' dijabete mellitus tattip 1.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated rash or dermatitis occurred in 30 (1.6%) patients, including Grade 3 in 7 (0.4%) patients.
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, raxx medjat mis-sistema immuni seħħ fi 30 (1.6%) pazjent, inkluż Grad 3 f'7 (0.4%) pazjenti.
English: Immune-mediated hypothyroidism and hyperthyroidism (including thyroiditis) occurred in patients receiving IMFINZI, and hypothyroidism may follow hyperthyroidism (see section 4.8).
Maltese: Seħħew ipotirojdiżmu u ipertirojdiżmu medjat mis-sistema immuni (inkluż tirojdite) f'pazjenti li rċivew IMFINZI, u l-ipotirojdiżmu jista' jsegwi l-ipertirojdiżmu (ara sezzjoni 4.8).
English: IMFINZI contains the active substance durvalumab which is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body.
Maltese: IMFINZI fih is-sustanza attiva durvalumab li hija antikorp monoklonali, tip ta' proteina mfassla biex tagħraf sustanza fil-mira speċifika fil-ġisem.
English: Immune-mediated myositis/polymyositis
Maltese: Mijożite/polimijożite medjata mis-sistema immuni
English: Of the 137 patients, 134 patients received hormone replacement therapy and two patients received high-dose corticosteroids (at least 40 mg prednisone or equivalent per day) for hypothyroidism followed by hormone replacement.
Maltese: Mill-137 pazjent, 134 pazjent irċivew terapija ta' sostituzzjoni talormoni u żewġ pazjenti rċivew kortikosterojdi ta' doża għolja (tal-inqas 40 mg prednisone jew ekwivalenti kuljum) għall-ipotirojdiżmu segwita minn sostituzzjoni tal-ormoni.
English: o includes pruritus generalised and pruritus.
Maltese: o tinkludi prurite ġeneralizzata u prurite.
English: Immune-mediated endocrinopathies
Maltese: Endokrinopatiji medjati mis-sistema immuni
English: Immune-mediated myocarditis
Maltese: Mijokardite medjata mis-sistema immuni
English: Patients should be monitored for signs and symptoms of infusion related reactions.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' reazzjonijiet relatati mal-infużjoni.
English: One patient also received mycophenolate treatment.
Maltese: Pazjent wieħed irċieva wkoll kura b'mycophenolate.
English: The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity, or a maximum of 12 months.
Maltese: Id-doża rakkomandata ta' IMFINZI hija 10 mg/kg mogħtija bħala infużjoni ġol-vini fuq 60 minuta kull ġimagħtejn, sal-progressjoni tal-marda jew tossiċità mhux aċċettabbli, jew massimu ta' 12-il xahar.
English: One vial of 2.4 mL of concentrate contains 120 mg of durvalumab.
Maltese: Kunjett wieħed ta' 2.4 mL ta' konċentrat fih 120 mg ta' durvalumab.
English: IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).
Maltese: IMFINZI bħala monoterapija huwa indikat għall-kura ta' adulti b'kanċer tal-pulmun lokalment avvanzat, li ma jistaxjitneħħa b'operazzjoni, b'ċelloli mhux żgħar (NSCLC, nonsmall cell lung cancer) fl-adulti li t-tumuri tagħhom jesprimu PD-L1 fuq ≥ 1% taċ-ċelloli tat-tumuri u li l-marda tagħhom ma pprogressatx wara terapija ta' kimoradjazzjoni bbażata fuq il-platinu (ara s-sezzjoni 5.1).
English: Durvalumab is produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
Maltese: Durvalumab jiġi prodott f'ċelluli mammiferi (ovarju tal-ħamster Ċiniż) permezz ta' teknoloġija rikombinanti tad-DNA.
English: Guidelines for management of immune-mediated adverse reactions are described in Table 1 (see section 4.4).
Maltese: Il-linji gwida għall-ġestjoni ta' reazzjonijiet avversi medjati mis-sistema immuni huma deskritti f'Tabella 1 (ara sezzjoni 4.4).
English: The median time to onset was 141 days (range: 70-265 days).
Maltese: Iż-żmien medjan għall-bidu kien ta' 141 jum (medda: 70265 jum).
English: l includes alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased and transaminases increased.
Maltese: l tinkludi żieda fl-alanina aminotransferażi, żieda fl-aspartataminotransferażi, żieda fl-enzima tal-fwied u żieda fit-transaminases. tinkludi epatite awtoimmuni, epatite tossika, korriment epatoċellulari, epatite akuta u epatotossiċità.
English: PFS at 12 months (%) (95% CI) PFS at 18 months (%) (95% CI) PFS2 Median PFS2
Maltese: HR (95% CI) Valur p b'2 naħat OS wara 24 xahar (%) (95% CI) valur p PFS Numru ta' episodji (%) PFS Medjana (xhur) (95% CI) HR (95% CI) valur p p < 0.0001
English: Warnings and precautions Talk to your doctor before you are given IMFINZI if:
Maltese: Twissijiet u prekawzjonijiet Kellem lit-tabib tiegħek qabel ma tingħata IMFINZI jekk:
English: Each mL of concentrate for solution for infusion contains 50 mg of durvalumab.
Maltese: Kull mL tal-konċentrat għal soluzzjoni għall-infużjoni fih 50 mg durvalumab.
English: If not used immediately, chemical and physical in-use stability of IMFINZI has been demonstrated for no more than 24 hours at 2°C to 8°C or 12 hours at room temperature up to 25°C from the time of vial puncture to the start of administration.
Maltese: Jekk ma tintużax immedjatament, l-istabbiltà kimika u fiżika waqt l-użu ta' IMFINZI ntweriet għal mhux aktar minn 24 siegħa f'2°C sa 8°C jew 12-il siegħa f'temperatura ambjentali sa' 25 C minn meta jinfetaħ il-kunjett sal-bidu tal-għoti.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100)
English: Immune-mediated hepatitis
Maltese: Epatite medjata mis-sistema immuni