FrancophonIA/ELRC3.0 huggingface dataset:
English: Includes reports of acne, acne pustular, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis bullous, dermatitis exfoliative generalised, drug eruption, eczema, eczema infected, erythema, erythema multiforme, erythema of eyelid, exfoliative rash, eyelid rash, fixed eruption, folliculitis, furuncle, generalised erythema, palmar-plantar erythrodysaesthesia syndrome, rash , rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash papulosquamous, rash pruritic, rash pustular, rash vesicular, seborrhoeic dermatitis, skin exfoliation, skin toxicity, skin ulcer, toxic epidermal necrolysis, toxic skin eruption.
Maltese: Jinkludi rapporti ta' akne, akne bil-ponot, dermatite, dermatite sura ta' akne, dermatite allerġika, dermatite blinfafet, dermatite esfoljattiva ġeneralizzata, reazzjoni allerġika fil-ġilda kkawżata mill-mediċina, ekżema, ekżema infettata, eritema, eritema multiforme, eritema tal-kappell tal-għajn, raxx esfoljattiv, raxx tal-kappell talgħajn, reazzjoni allerġika fl-istess post fil-ġilda kkawżata mill-mediċina, follikulite, furunklu, eritema ġeneralizzata, sindrome ta' eritrodisasteżija palmari-plantari, raxx, raxx b'eritema, raxx ġeneralizzat, raxx makulari, raxx makulo-papulari, raxx papulari, raxx papuloskwamuż, raxx bil-ħakk, raxx bil-ponot, raxx blinfafet, dermatite tas-saborrea, esfoljazzjoni tal-ġilda, tossiċità tal-ġilda, ulċera fil-ġilda, nekrolisi tossika talepidermide, eruzzjoni tossika tal-ġilda.
English: Other endpoints Investigator-assessed ORR (RECIST 1.1)** ^
Maltese: Punti finali oħra ORR stmata mill-investigatur (RECIST 1.1) ** ^
English: Common influenza like illness, chills a
Maltese: Komuni marda tixbah lillinfluwenza, sirdat a
English: Pancreatitis, including increases in serum amylase and lipase levels, has been observed in clinical trials with atezolizumab (see section 4.8).
Maltese: Pankreatite, inklużi żidiet fil-livelli ta' amylase u lipase fis-serum, kienet osservata fi provi kliniċi b'atezolizumab (ara sezzjoni 4.8).
English: Overall, 41% of enrolled patients had PD-L1 expression ≥1%, 27% had liver metastases and 7% asymptomatic brain metastases at baseline.
Maltese: B'mod globali, 41% tal-pazjenti rreġistrati kellhom espressjoni ta' PD-L1 ta' ≥ 1%, 27% kellhom metastasi fil-fwied u 7% kellhom metastasi asintomatika fil-moħħ fil-linja bażi.
English: Figure 3: Forest plot of overall survival by PD-L1 expression in the ITT population, Arm B vs. C (IMpower150)
Maltese: Figura 3: Forest plot tas-sopravivenza globali skont l-espressjoni ta' PD-L1 fil-popolazzjoni ITT, Grupp B vs. C (IMpower150)
English: Figure 9: Forest plot of progression free survival by PD-L1 expression (IMpower130)
Maltese: Figura 9: Forest plot ta' sopravivenza mingħajr progressjoni skont l-espressjoni ta' PD-L1 (IMpower130)
English: 89 mL/min/1.73 m2; n=208) or, moderate (eGFR 30 to 59 mL/min/1.73 m2; n=116) renal impairment compared to patients with normal (eGFR greater than or equal to 90 mL/min/1.73 m2; n=140) renal function.
Maltese: 30 sa 59 mL/min/1.73 m 2; n=116) meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi (eGFR akbar minn jew ugwali għal 90 mL/min/1.73 m 2; n=140).
English: Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):
Maltese: Tecentriq bħala monoterapija huwa indikat għat-trattament ta' pazjenti adulti b'karċinoma avvanzata lokalment jew metastatika tal-epitelju tal-apparat urinarju (UC - urothelial carcinoma):
English: z Includes reports of proteinuria, protein urine present, haemoglobinurea, nephrotic syndrome.
Maltese: Tinkludi rapporti ta' proteinurja, preżenza ta' proteina fl-awrina, emoglobinurja, sindrome nefrotiku.
English: 12-month OS (%)**
Maltese: OS ta' 12-il xahar (%)**
English: • numbness or paralysis, which may be signs of Guillain-Barré syndrome
Maltese: • tnemnim jew paralisi, li jistgħu jkunu sinjali tas-sindrome ta' Guillain-Barré
English: Tel: +371 - 6 7039831
Maltese: Roche Latvija SIA Tel: +371 - 6 7039831
English: + carboplatin (AUC 6)
Maltese: + carboplatinc (AUC 6)
English: In Cohort 2, the co-primary efficacy endpoints were confirmed ORR as assessed by an IRF using RECIST v1.1 and investigator-assessed ORR according to Modified RECIST (mRECIST) criteria.
Maltese: F'Koorti 2, il-punti finali koprimarji tal-effikaċja kienu ORR ikkonfermata kif stmata minn IRF permezz ta' RECIST v1.1 u ORR stmata mill-investigatur skont kriterji RECIST Modifikati (mRECIST - Modified RECIST).
English: The stratified log-rank p-value was 0.41 and therefore the results are considered not statistically significant in this population.
Maltese: Il-valur p log-rank stratifikat kien ta' 0.41 u għalhekk irriżultati huma kkunsidrati li mhumiex statistikament sinifikanti f'din il-popolazzjoni.
English: The median age was 63 years (range: 31 to 90), and 60% of patients were male.
Maltese: L-età medjana kienet ta' 63 sena (medda: 31 sa 90), u 60% talpazjenti kienu rġiel.
English: The prescriber must discuss the risks of Tecentriq therapy with the patient.
Maltese: Minn jippreskrivi għandu jiddiskuti r-riskji ta' terapija b'Tecentriq mal-pazjent.
English: Clinically relevant IRF-assessed ORRs per RECIST v1.1 were shown; however, when compared to a pre-specified historical control response rate of 10%, statistical significance was not reached for the primary endpoint.
Maltese: Intwerew ORRs klinikament rilevanti stmati minn IRF skont RECIST v1.1; madankollu, meta mqabbla ma' rata ta' rispons ta' 10% b'kontroll storiku speċifikat minn qabel, is-sinifikat statistiku għall-punt finali primarju ma ntlaħaqx.
English: Investigator-assessed PFS (RECIST v1.1) **
Maltese: PFS stmata mill-investigatur (RECIST v1.1) **
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 840 mg/14 mL
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 840 mg/14 mL
English: * Exploratory OS final analysis at clinical cut-off 24 January 2019 ** PFS, ORR and DOR analyses at clinical cut-off 24 April 2018 *** For descriptive purposes only ^ Confirmed ORR and DoR are exploratory endpoints
Maltese: Stratifikat skont is-sess u l-istat ta' eżekuzzjoni ta' ECOG * Analiżi finali esploratorja ta' OS fiż-żmien tal-waqfien kliniku fl-24 ta' Jannar 2019 ** Analiżi ta' PFS, ORR u DOR fiż-żmien tal-waqfien kliniku fl-24 ta' April 2018 *** Għal skopijiet deskrittivi biss ^ ORR u DOR ikkonfermati huma punti finali esploratorji
English: Among 107 Arm B patients who had a response status of stable disease, partial response, or complete response after induction therapy, 40 received pemetrexed switch maintenance therapy.
Maltese: Fost 107 pazjenti talGrupp B li kellhom stat ta' rispons ta' marda stabbli, rispons parzjali, jew rispons komplet wara terapija ta' induzzjoni, 40 irċevew terapija ta' manteniment ta' qlib għal pemetrexed.
English: Diabetes mellitus led to the discontinuation of atezolizumab in < 0.1% (3/3,178) patients.
Maltese: Dijabete mellitus wasslet għall-waqfien ta' atezolizumab f'< 0.1% (3/3,178) tal-pazjenti.
English: Arm A (Atezolizumab + carboplatin + etoposide)
Maltese: Grupp A (Atezolizumab + carboplatin + etoposide)
English: Figure 1: Kaplan-Meier curve for overall survival (IMvigor211)
Maltese: Kaplan-Meier għas-sopravivenza globali (IMvigor211)
English: h Includes reports of hyperthyroidism, Basedow's disease, endocrine ophthalmopathy, exophthalmos.
Maltese: h Jinkludi rapporti ta' ipertirojdiżmu, marda ta' Basedow, oftalmopatija endokrinali, exoftalmos.
English: Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab
Maltese: Tecentriq 1,200 mg konċentrat għal soluzzjoni għall-infużjoni atezolizumab
English: *Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Maltese: IgG1 umanizzat, kontra death-ligand 1 ipprogrammat (PD-L1 - programmed death-ligand 1), Fc-engineered, magħmul f'ċelluli tal-ovarju tal-Ħamster Ċiniż permezz ta' teknoloġija tat-tfassil tad-DNA.
English: A statistically significant improvement in OS was observed with atezolizumab in combination with carboplatin and etoposide compared to the control arm (HR of 0.70, 95% CI: 0.54, 0.91; median OS of 12.3 months vs. 10.3 months).
Maltese: Ġie osservat titjib statistikament sinifikanti f'OS b'atezolizumab flimkien ma' carboplatin u etoposide meta mqabbel mal-grupp ta' kontroll (HR ta' 0.70, CI ta' 95%: 0.54, 0.91; OS medjana ta' 12.3 xhur vs. 10.3 xhur).
English: Atezolizumab spares the PD-L2/PD-1 interaction allowing PD-L2/PD-1 mediated inhibitory signals to persist.
Maltese: Atezolizumab ma jħallix l-interazzjoni PD-L2/PD-1 u jippermetti li sinjali inibitorji medjati minn PD-L2/PD-1 jippersistu.
English: Patients who had prior treatment with CD137 agonists or immune checkpoint blockade therapies (anti-PD-1, and anti-PD-L1 therapeutic antibodies) were not eligible.
Maltese: Pazjenti li ngħataw trattament minn qabel b'agonisti ta' CD137 jew terapiji ta' imblokk ta' checkpoint immuni (antikorpi terapewtiċi kontra PD-1, u kontra PD-L1) ma kinux eliġibbli.
English: Elderly Based on a population pharmacokinetic analysis, no dose adjustment of Tecentriq is required in patients ≥ 65 years of age (see sections 4.8 and 5.1).
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni, mhux meħtieġ aġġustament fid-doża ta' Tecentriq f'pazjenti ta' età ≥ 65 sena (ara sezzjonijiet 4.8 u 5.1).
English: Treatment with atezolizumab should be permanently discontinued for Grade 4, or any grade of recurrent pancreatitis.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf b'mod permanenti għal Grad 4, jew kwalunkwe grad ta' pankreatite rikorrenti.
English: No data are available to allow conclusions to be drawn on possible effects of neutralising antibodies.
Maltese: M'hemm l-ebda data disponibbli li tippermetti li jinsiltu konklużjonijiet dwar effetti possibbli tannewtralizzazzjoni tal-antikorpi.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 840 mg/14 mL
Maltese: INDIVIDWALI 840 mg/14 mL
English: Chemical and physical in-use stability has been demonstrated for up to 24 hours at ≤ 30 °C and for up to 30 days at 2 °C to 8 °C from the time of preparation.
Maltese: Stabbiltà kimika u fiżika waqt l-użu intweriet sa 24 siegħa f'temperatura ta' ≤ 30°C u sa 30 jum f'temperatura ta' 2°C sa 8°C mill-ħin tal-preparazzjoni.
English: Chemical and physical in-use stability has been demonstrated for up to 24 hours at ≤ 30 °C and for up to 30 days at 2°C to 8°C from the time of preparation.
Maltese: Stabbiltà kimika u fiżika waqt l-użu intweriet sa 24 siegħa f'temperatura ta' ≤ 30°C u sa 30 jum f'temperatura ta' 2 °C sa 8 °C mill-ħin tal-preparazzjoni.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,200 mg/20 mL
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 1,200 mg/20 mL
English: Comparisons with respect to OS between the treatment arm and control arm within the IC2/3, IC1/2/3, and ITT (Intention-to-treat, i.e. all comers) populations were tested using a hierarchical fixed-sequence procedure based on a stratified log-rank test at two-sided level of 5% as follows: step 1) IC2/3 population; step 2) IC1/2/3 population; step 3) all comers population.
Maltese: It-tqabbil fir-rigward tal-OS bejn grupp ta' trattament u grupp ta' kontroll fi ħdan il-popolazzjonijiet ta' IC2/3, IC1/2/3, u ITT (Intention-to-treat, jiġifieri l-pazjenti kollha rreġistrati) kien ittestjat bl-użu ta' proċedura ta' sekwenza fissa ġerarkika abbażi ta' test log-rank stratifikat f'livell b'żewġ naħat ta' 5% kif ġej: ilpass 1) popolazzjoni ta' IC2/3; il-pass 2) popolazzjoni ta' IC1/2/3; il-pass 3) popolazzjoni tal-pazjenti kollha rreġistrati.
English: Table 12: Summary of efficacy (IMpower133) Key efficacy endpoints
Maltese: Tabella 12: Sommarju tal-effikaċja (IMpower133) Punti finali ewlenin tal-effikaċja
English: Figure 4: Kaplan-Meier curve for PFS in the ITT population (IMpower150)
Maltese: Kaplan-Meier għal PFS fil-popolazzjoni ITT (IMpower150)
English: Treatment with atezolizumab must be permanently discontinued for any grade of myasthenic syndrome / myasthenia gravis or Guillain-Barré syndrome.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf b'mod permanenti għal kwalunkwe grad ta' sindrome majastenika / majastenja gravis jew sindrome ta' Guillain-Barré.
English: Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Maltese: Tecentriq flimkien ma' nab-paclitaxel huwa indikat għat-trattament ta' pazjenti adulti b'kanċer tassider triple-negative (TNBC - triple-negative breast cancer) avvanzat lokalment jew metastatiku li ma jistax jitneħħa permezz ta' kirurġija li t-tumuri tagħhom għandhom espressjoni ta' PD-L1 ta' ≥ 1% u li ma rċevewx kimoterapija qabel għal mard metastatiku.
English: Immune system disorders Common infusion-related reactionf Endocrine disorders Very common hypothyroidismg
Maltese: Disturbi fis-sistema endokrinarja Komuni ħafna ipotirojdiżmu g
English: Table 11: Intravenous treatment regimens (IMpower133) Treatment regimen
Maltese: Tabella 11: Korsijiet ta' trattament fil-vini (IMpower133) Kors ta' trattament
English: If symptoms improve to ≤ Grade 1, taper corticosteroids as clinically indicated.
Maltese: Jekk is-sintomi jitjiebu għal ≤ Grad 1, naqqas il-kortikosterojdi għax-xejn kif klinikament indikat.
English: The median duration was 8.0 months (range 18 days to 8.3+ months; + denotes a censored value).
Maltese: It-tul ta' żmien medjan kien ta' 8.0 months (medda minn 18-il jum sa 8.3+ xhur; + jindika valur iċċensurat).
English: or blood bilirubin > 1.5 to 3 x ULN)
Maltese: jew bilirubina fid-demm > 1.5 sa 3 x ULN)
English: 95% CI: 0.63, 1.72 for OS, respectively).
Maltese: 87 (CI ta' 95%: 0.63, 1.21).
English: The median age was 64 years (range: 26 to 90 years) with 10% of patients ≥75 years of age.
Maltese: L-età medjana kienet ta' 64 sena (medda: 26 sa 90 sena) b'10% talpazjenti b'età ta' ≥75 sena.
English: The median duration was 2.8 months (range 15 days to 9.5+ months; + denotes a censored value).
Maltese: It-tul ta' żmien medjan kien ta' 2.8 ijiem (medda minn 15-il jum sa 9.5+ xhur; + jindika valur iċċensurat).
English: The median age was 64 years (range 18 to
Maltese: L-età medjana kienet ta' 64 sena (medda minn 18 sa 86 sena).
English: NSCLC patients (hazard ratio [HR] of 0.73, 95% CI: 0.60, 0.89; median OS of 15.6 vs. 11.2 months for atezolizumab and docetaxel, respectively) and squamous NSCLC patients (HR of 0.73, 95% CI: 0.54, 0.98; median OS of 8.9 vs. 7.7 months for atezolizumab and docetaxel, respectively).
Maltese: 11.2 xhur għal atezolizumab u docetaxel, rispettivament) u f'pazjenti b'NSCLC skwamuż (HR ta' 0.73, CI ta' 95%: 0.54, 0.98; OS medjana ta' 8.9 vs. 7.7 xhur għal atezolizumab u docetaxel, rispettivament).
English: • 1,680 milligrams (mg) every four weeks.
Maltese: • 1,680 milligramma (mg) kull erba' ġimgħat.
English: Rash
Maltese: Roche
English: No. of complete response (%) No. of partial response (%)
Maltese: Nru. ta' rispons komplet (%) Nru. ta' rispons parzjali (%)
English: For the description of Tecentriq trials, refer to the Tecentriq 1,200 mg concentrate for solution for infusion Summary of Product Characteristics (SmPC) section 5.1.
Maltese: Għad-deskrizzjoni tal-provi ta' Tecentriq, irreferi għas-sezzjoni 5.1 tas-Sommarju tal-Karatteristiċi talProdott (SmPC - Summary of Product Characteristics) ta' Tecentriq 1,200 mg konċentrat għal soluzzjoni għall-infużjoni.
English: Figure 11: Forest plot of overall survival by PD-L1 expression in the primary analysis population (OAK)
Maltese: Figura 11: Forest plot tas-sopravivenza globali skont l-espressjoni ta' PD-L1 fil-popolazzjoni talanaliżi primarja (OAK)
English: Table 9: Summary of efficacy from IMpower130 in the primary analysis (ITT-WT population) Efficacy endpoints
Maltese: Tabella 9: Sommarju tal-effikaċja minn IMpower130 fl-analiżi primarja (popolazzjoni ITT-WT)
English: The most common adverse reactions (≥ 20%) were nausea (37.4%), fatigue (36.4%), neutropenia (33.7%), anaemia (33.2%), diarrhoea (29.5%), rash (28.5%), constipation (27.0%), peripheral neuropathy (26.8%), decreased appetite (24.6%), thrombocytopenia (21.2%) and cough (20.1%).
Maltese: L-aktar reazzjonijiet avversi komuni (≥ 20%) kienu dardir (37.4%), għeja kbira (36.4%), newtropenija (33.7%), anemija (33.2%), dijarea (29.5%), raxx (28.5%), stitikezza (27.0%), newropatija periferali
English: Chemotherapy (n = 464)
Maltese: Kimoterapija (n = 464)
English: g Includes reports of autoimmune hypothyroidism, autoimmune thyroiditis, blood thyroid stimulating hormone abnormal, blood thyroid stimulating hormone decreased, blood thyroid stimulating hormone increased, euthyroid sick syndrome, goitre, hypothyroidism, myxoedema, thyroid disorder, thyroid function test abnormal, thyroiditis, thyroiditis acute, thyroxine decreased, thyroxine free decreased, thyroxine free increased, thyroxine increased, tri-iodothyronine decreased, tri-iodothyronine free abnormal, tri-iodothyronine free decreased, tri-iodothyronine free increased.
Maltese: g Jinkludi rapporti ta' ipotirojdiżmu awtoimmuni, tirojdite awtoimmuni, ormon mhux normali li jistimula ttirojde fid-demm, tnaqqis tal-ormon li jistimula t-tirojde fid-demm, żieda tal-ormon li jistimula t-tirojde fiddemm, sindrome ta' utirojde marida, għanqra, ipotirojdiżmu, miksoedima, disturb fit-tirojde, test tal-funzjoni tattirojde mhux normali, tirojdite, tirojdite akuta, tnaqqis ta' thyroxine, tnaqqis ta' thyroxine ħieles, żieda ta' thyroxine ħieles, żieda ta' thyroxine, tnaqqis ta' tri-iodothyronine, tri-iodothyronine ħieles mhux normali, tnaqqis ta' tri-iodothyronine ħieles, żieda ta' tri-iodothyronine ħieles.
English: EU/1/17/1220/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1220/002
English: The maximum systemic accumulation ratio across dosing regimens is 3.3.
Maltese: Il-proporzjon tal-akkumulazzjoni sistemika massima matul il-korsijiet ta' dożaġġ huwa ta' 3.3.
English: The Adverse Drug Reactions (ADRs) are listed by MedDRA system organ class (SOC) and categories of frequency in Table 2 for atezolizumab given as monotherapy or as combination therapy.
Maltese: Ir-Reazzjonijiet Avversi tal-Mediċina (ADRs - Adverse Drug Reactions) huma elenkati skont il-klassi tas-sistemi u tal-organi (SOC - system organ class) MedDRA u l-kategoriji ta' frekwenza fit-Tabella 2 għal atezolizumab mogħti bħala monoterapija jew bħala terapija kombinata.
English: or blood bilirubin > 3 x ULN)
Maltese: jew bilirubina fid-demm > 3 x ULN)
English: A phase III, open-label, randomised study, GO29537 (IMpower130), was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel and carboplatin, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Maltese: III, open-label u randomised, GO29537 (IMpower130), twettaq biex jiġu evalwati leffikaċja u s-sigurtà ta' atezolizumab flimkien ma' nab-paclitaxel u carboplatin, f'pazjenti b'NSCLC metastatiku u mhux skwamuż li qatt ma rċevew kimoterapija fil-passat.
English: Each 14 mL vial of concentrate contains 840 mg atezolizumab After dilution, 1 mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
Maltese: Kull kunjett ta' 14 mL ta' konċentrat fih 840 mg atezolizumab Wara d-dilwizzjoni, 1 ml ta' soluzzjoni fih madwar 3.2 mg ta' atezolizumab għal doża ta' 840 mg u 6.0 mg ta' atezolizumab għal doża ta' 1,680 mg.
English: Patients were randomised (1:1) to receive either atezolizumab or docetaxel.
Maltese: Il-pazjenti kienu randomised (1:1) biex jirċievu atezolizumab jew docetaxel.
English: In the population pharmacokinetic analysis, there were no clinically important differences in the clearance of atezolizumab between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 × to 1.5 × ULN and any AST, n= 71) and normal hepatic function (bilirubin and AST ≤
Maltese: Fl-analiżi talfarmakokinetika tal-popolazzjoni, ma kienx hemm differenzi klinikament importanti fit-tneħħija ta' atezolizumab bejn pazjenti b'indeboliment ħafif tal-fwied (bilirubina ≤ ULN u AST > ULN jew bilirubina > 1.0 × sa 1.5 × ULN u kwalunkwe AST, n= 71) u funzjoni normali tal-fwied (bilirubina u AST ≤ ULN, n = 401).
English: Primary efficacy endpoint OS
Maltese: Punt finali primarju tal-effikaċja OS
English: Hepatic impairment was defined by the National Cancer Institute (NCI) criteria of hepatic dysfunction (see section 4.2).
Maltese: Indeboliment tal-fwied kien definit permezz tal-kriterji tal-Istitut Nazzjonali tal-Kanċer (NCINational Cancer Institute) ta' disfunzjoni tal-fwied (ara sezzjoni 4.2).
English: No incompatibilities have been observed between Tecentriq and intravenous bags with product-contacting surfaces of polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP).
Maltese: Ma ġiet osservata l-ebda inkompatibbiltà bejn Tecentriq u boroż tal-infużjoni fil-vina b'uċuħ f'kuntatt mal-prodott tal-polyvinyl chloride (PVC), tal-polyolefin (PO), tal-polyethylene (PE), jew talpolypropylene (PP).
English: Atezolizumab is an Fc-engineered, humanised immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumour immune response without inducing antibody-dependent cellular cytotoxicity.
Maltese: Atezolizumab huwa antikorp monoklonali immunoglobulina G1 (IgG1 - immunoglobulin G1) umanizzat, Fc-engineered, li jeħel direttament ma' PD-L1 u jipprovdi imblokk doppju tar-riċetturi PD-1 u B7.1, billi jerħi inibizzjoni medjata minn PD-L1/PD-1 tar-rispons immuni, inkluż attivazzjoni mill-ġdid tar-rispons immune kontra t-tumur mingħajr ma jinduċi ċitotossiċità ċellulari dipendenti mill-antikorpi.
English: Exploratory subgroup analyses were performed in patients with PD-L1 expression ≥ 1%, exploring prior (neo)adjuvant treatment, BRCA1/2 mutation and asymptomatic brain metastases at baseline.
Maltese: Twettqu analiżi esploratorji tas-sottogrupp f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1%, li esploraw trattament (neo)awżiljarju minn qabel, mutazzjoni BRCA1/2 u metastasi asintomatika fil-moħħ fillinja bażi.
English: Baseline ECOG performance status was 0 (37%) or 1 (63%).
Maltese: Stat ta' eżekuzzjoni ta' ECOG fil-linja bażi kien ta' 0 (37%) jew 1 (63%).
English: Dose delay or discontinuation (see also sections 4.4 and 4.8) Table 1: Dose modification advice for Tecentriq
Maltese: Ittardjar jew twaqqif tad-doża (ara wkoll sezzjonijiet 4.4 u 4.8) Tabella 1: Parir dwar modifikazzjoni tad-doża għal Tecentriq
English: Patients with PD-L1 expression <1% did not show improved OS when atezolizumab was added to nab-paclitaxel (HR of 0.97, 95% CI 0.78, 1.20).
Maltese: Il-pazjenti b'espressjoni ta' PD-L1 ta' < 1% ma wrewx OS imtejba meta atezolizumab żdied ma' nab-paclitaxel (HR ta' 0.97, CI ta' 95% 0.78, 1.20).
English: The observed OS improvement was consistently demonstrated across subgroups of patients including those with brain metastases at baseline (HR of 0.54, 95% CI: 0.31, 0.94; median OS of 20.1
Maltese: It-titjib osservat f'OS kien muri b'mod konsistenti tul is-sottogruppi ta' pazjenti inklużi dawk b'metastasi fil-moħħ fil-linja bażi (HR ta' 0.54, CI ta' 95%: 0.31, 0.94; OS medjana ta' 20.1 vs.
English: POPLAR (GO28753): Randomised phase II trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
Maltese: POPLAR (GO28753): Prova randomised ta' fażi
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi kliniċi ta' endokrinopatiji.
English: After dilution, one mL of solution should contain approximately 6.0 mg of Tecentriq (1680 mg/278 mL).
Maltese: Wara ddilwizzjoni, mL wieħed ta' soluzzjoni għandu jkun fih bejn wieħed u ieħor 6.0 mg ta' Tecentriq (1,680 mg/278 mL).