FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk management plan has been developed to ensure that Palonosetron Accord is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Palonosetron Accord jintuża bl-aktar mod sigur possibbli.
English: How does Palonosetron Accord work?
Maltese: Kif jaħdem Palonosetron Accord?
English: Why is Palonosetron Accord approved?
Maltese: Għaliex ġie approvat Palonosetron Accord?
English: The Committee recommended that Palonosetron Accord be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Palonosetron Accord ikun approvat għall-użu fl-UE.
English: The company provided data from the published literature on palonosetron.
Maltese: Il-kumpanija pprovdiet dejta minn dokumentazzjoni ppubblikata dwar palonosetron.
English: How has Palonosetron Accord been studied?
Maltese: Kif jintuża Palonosetron Accord?
English: EMEA/H/C/000572/WS/007 EMEA/H/C/000573/W
Maltese: EMEA/H/C/000552/WS/0076 EMEA/H/C/000572/WS/0076 EMEA/H/C/000573/WS/0076
English: Ariclaim, Cymbalta and Xeristar are medicines containin
Maltese: Ariclaim, Cymbalta u Xeristar huma mediċini li fihom is-sustanza attiva duloxetine.
English: The medicines are expected to work in the same way they do in diabetic periphera active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Issustanza attiva duloxetine, hija inibitur ta' teħid mill-ġdid ta' serotonin-noradrenaline.
English: (duloxetine)
Maltese: Mistoqsijiet u tweġibiet
English: Page 2/2
Maltese: 17 ta' Novembru 2011
English: musculoskeletal tissues (such as skeletal musc internal organs such as the stomac
Maltese: Ma jinkludix uġigħ minn organi interni bħall-istonku u intestini.
English: The CHMP noted that the studies had not proven that duloxetine would provide a r the indication applied for.
Maltese: Is-CHMP innota li l-istudji ma tawx prova li duloxetine jipprovdi benefiċċju relevanti fl-indikazzjoni li saret applikazzjoni għaliha.
English: ts of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in ne or placebo (a nts taking them in combination with NSAIDs.
Maltese: Il-kumpanija ppreżentat riżultati minn ħames studji ewlenin fi 839 pazjent b'uġigħ somatiku kroniku: żewġ studji f'pazjenti b'uġigħ fl-irkoppa kkawżat minn osteoartrite (nefħa u uġigħ fil-ġogi) u tlieta f'pazjenti b'uġigħ kroniku fil-parti t'isfel tad-dahar.
English: It works by preventi the neurotransmitters 5-hydroxytrypamine (also called serotonin) and no back up into nerve cells in the brain and spinal cord.
Maltese: Taħdem billi timpedixxi lin-newrotrasmettituri 5-hydroxytrypamine (imsejjaħ ukoll serotonin) u noradrenaline milli jittieħdu mill-ġdid fiċ-ċelloli tan-nervituri fil-moħħ u fil-korda spinali.
English: MP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar.
Maltese: Fil-21 ta' Lulju 2011, il-Kumitat għall-Prodotti Meċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li tirrakkomanda r-rifjut ta' bidla għall-awtorizzazzjonijiet għat-tqegħid fis-suq għall-mediċini li fihom duloxetine, jiġifieri Ariclaim, Cymbalta u Xeristar.
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage extremities that can occur in patients with diabetes).
Maltese: Ariclaim jintuża biex jikkura uġigħ dovut għal newropatija periferali (ħsara lin-nervituri fl-estremitajiet li tista' sseħħ f'pazjenti bid-dijabete).
English: the change to the authorisation is Eli Lilly.
Maltese: Il-kumpanija li applikat għall-bidla għall-awtorizzazzjoni hija Eli Lilly.
English: l neuropathy.
Maltese: Riżultat ta' eżaminazzjoni mill-ġdid
English: Patients in the studies were treated with duloxeti dummy treatment) with some patie effectiveness was the change in the severity of pain, as recorded by the patients after 12 or 13 weeks of treatment.
Maltese: Barra minn hekk, kien hemm bżonn ta' aktar informazzjoni fuq l-effetti ta' duloxetine f'pazjenti anzjani u dwar is-sigurtà tiegħu fil-pazjenti filmira inkluż l-anzjani.
English: Ireland Roche Products (Ireland) Ltd.
Maltese: Roche Products (Ireland) Ltd.
English: ATC code: L01XC32
Maltese: L01XC32
English: Based on the stratified log-rank test.
Maltese: Ibbażat fuq test log-rank stratifikat.
English: Primary efficacy endpoints n=185
Maltese: Punti finali primarji tal-effikaċja n=185
English: • low levels of adrenal hormones
Maltese: • livelli baxxi ta' ormoni adrenali
English: p-value**
Maltese: Valur p**
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: România Roche România S.R.L.
Maltese: Roche România S.R.L.
English: Common syncope
Maltese: Komuni sinkope
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Event Version 4.0 (NCI-CTCAE v.4.
Maltese: Avvenimenti Avversi Verżjoni 4.0 (NCI-CTCAE v.4. - National Cancer Institute Common Terminology Criteria for Adverse Event Version 4.0.).
English: Rare nephritisaa
Maltese: Rari nefriteaa
English: Includes report of nephritis, Henoch-Schonlein Purpura nephritis.
Maltese: Tinkludi rapporti ta' nefrite, nefrite Henoch-Schonlein Purpura.
English: • The active substance is atezolizumab.
Maltese: • Is-sustanza attiva hi atezolizumab.
English: • protein in urine (proteinuria)
Maltese: • proteina fl-awrina (proteinurja)
English: Sverige Roche AB
Maltese: Roche AB
English: Pack of one vial.
Maltese: Pakkett ta' kunjett wieħed.
English: 79639 Grenzach-Whylen
Maltese: 79639 Grenzach-Whylen IL-ĠERMANJA
English: • Give you other medicines to prevent complications and reduce symptoms.
Maltese: • Jagħtik mediċini oħra biex jipprevjeni komplikazzjonijiet u jnaqqas s-sintomi.
English: ‡^ (95% CI)
Maltese: ‡^ (CI ta' 95%)
English: (neutropenia, leukopenia)
Maltese: (newtropenija, lewkopenija)
English: Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
Maltese: Stat ta' eżekuzzjoni tal-Grupp Kooperattiv tal-Lvant għall-Onkoloġija (ECOG - Eastern Cooperative Oncology Group) ta' ≥ 2
English: Grade 3 or 4: (ALT or AST > 5 x ULN
Maltese: Grad 3 jew 4 (ALT jew AST > 5 x ULN
English: Hrvatska Roche d.o.o.
Maltese: Roche d.o.o.
English: 14.1 (9.2, NE) 15.9 (10.4, NE)
Maltese: 14.1 (9.2, NE) 15.
English: j Includes reports of adrenal insufficiency and primary adrenal insufficiency.
Maltese: j Tinkludi rapporti ta' insuffiċjenza adrenali u insuffiċjenza adrenali primarja.
English: o Incudes reports of myasthenia gravis.
Maltese: o Jinkludi rapporti ta' majastenja gravis.
English: PD-L1 expression of ≥ 1% in IC
Maltese: PD-L1 ta' ≥ 1% f'IC
English: OS results were similar for patients aged < 65 and ≥ 65 subgroups, respectively.
Maltese: Ir-riżultati tal-OS kienu simili għal sottogruppi ta' pazjenti b'età ta' < 65 u ≥ 65, rispettivament.
English: • inflammation of muscles (myositis)
Maltese: • infjammazzjoni tal-muskoli (mijosite)
English: Your first infusion will be given over 60 minutes.
Maltese: L-ewwel infużjoni tiegħek se tingħata fuq medda ta' 60 minuta.
English: The following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Maltese: Intużaw il-kategoriji ta' frekwenza li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1000), rari ħafna (< 1/10,000).
English: Grade 2:
Maltese: Grad 2:
English: Rare hypophysitisk
Maltese: Rari ipofisitek
English: Treatment modification
Maltese: Modifikazzjoni tat-trattament
English: No clinically important difference was observed in the pharmacokinetics of atezolizumab among patients < 65 years (n=274), patients between 65−75 years (n=152) and patients > 75 years (n=46) (see section 4.2).
Maltese: Ma kinux osservati differenzi ta' importanza klinika fil-farmakokinetika ta' atezolizumab fost pazjenti ta' < 65 sena (n=274), pazjenti bejn 65−75 sena (n=152) u pazjenti > 75 sena (n=46) (ara sezzjoni 4.2).
English: • Store in a refrigerator (2 °C - 8 °C).
Maltese: • Aħżen fi friġġ (2 °C - 8 °C).
English: 12-month OS (%)*** 18-month OS (%)***
Maltese: OS ta' 12-il xahar (%)*** OS ta' 18-il xahar (%)***
English: The median age was 55 years (range: 20-86).
Maltese: L-età medjana kienet ta' 55 sena (medda: 20-86).
English: Grade 2: (ALT or AST > 3 to 5 x upper limit of normal [ULN]
Maltese: Grad 2: (ALT jew AST > 3 sa 5 x il-limitu ta' fuq tan-normal [ULN - upper limit of normal]
English: Maintenance (21-Day Cycles)
Maltese: Manteniment (Ċikli ta' 21 Jum)
English: Maintenance (21-day cycles)
Maltese: Manteniment (ċikli ta' 21 jum)
English: Symptomatic
Maltese: Sintomatika
English: Grade 3 or 4 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L)
Maltese: Ipergliċemija ta' Grad 3 jew 4 (livell ta' glucose meta l-pazjent ikun sajjem > 250 mg/dL jew 13.9 mmol/L)
English: b etoposide (100 mg/m2)b,c atezolizumab (1,200 mg)
Maltese: + etoposide (100 mg/m2)b,c atezolizumab (1,200 mg) a
English: • inflammation of the lungs (pneumonitis)
Maltese: • infjammazzjoni tal-pulmun (pulmonite)
English: Incudes reports of hypophysitis and temperature regulation disorder.
Maltese: Tinkludi rapporti ta' ipofisite u disturb fir-regolazzjoni tat-temperatura.
English: OS interim analysis*
Maltese: Analiżi interim ta' OS*
English: Uncommon pancreatitisu
Maltese: Mhux komuni pankreatite u
English: Permanently discontinue Tecentriq (except endocrinopathies controlled with replacement hormones)
Maltese: Waqqaf Tecentriq b'mod permanenti (ħlief għal endokrinopatiji kkontrollati b'ormoni ta' sostituzzjoni)
English: (creatinine level > 1.5 to 3.0 x baseline or > 1.5 to 3.0 x ULN)
Maltese: (livell tal-kreatinina ta' > 1.5 sa 3.0 x linja bażi jew ta' > 1.5 sa 3.0 x ULN)
English: Grade 3 or 4: (creatinine level > 3.0 x baseline or > 3.0 x ULN)
Maltese: Grad 3 jew 4: (livell tal-kreatinina ta' > 3.0 x linja bażi jew ta' > 3.0 x ULN)
English: • Absence of tumour progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be readily managed and stabilised by protocol-allowed medical interventions prior to repeat dosing
Maltese: • Nuqqas ta' progressjoni tat-tumur f'siti anatomiċi kritiċi (eż., marda leptomeninġali) li ma jistax jiġi mmaniġġjat faċilment u stabilizzat permezz ta' interventi mediċi permessi mill-protokoll qabel ma jiġi ripetut id-dożaġġ
English: • have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome
Maltese: • għandek infezzjoni bil-virus tal-immunodefiċjenza umana (HIV) jew sindromu akkwiżit ta'
English: Tlf: +47 - 22 78 90 00
Maltese: Roche Norge AS Tlf: +47 - 22 78 90 00
English: A total of 931 patients were enrolled.
Maltese: Kienu rreġistrati total ta' 931 pazjent.
English: The rate of complete response per IRF-RECIST v1.1 in the all comer population was 6.1% (95% CI: 3.7, 9.4).
Maltese: Ir-rata ta' rispons komplet skont IRF-RECIST v1.1 fil-popolazzjonijiet tal-pazjenti kollha rreġistrati kienet ta' 6.1% (CI ta' 95%: 3.7, 9.4).
English: placebo + carboplatin (AUC 5)
Maltese: plaċebo + carboplatin (AUC 5)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' Settembru 2017
English: Placebo + nab-paclitaxel
Maltese: Plaċebo + nab-paclitaxel
English: Uncommon Guillain-Barré syndromem, meningoencephalitisn
Maltese: Mhux komuni sindrome ta' Guillain-Barrém, meningoenċefaliten
English: ǂ Stratified by chemotherapy (vinflunine vs. taxane), status on IC (< 5% vs. ≥ 5%), number of prognostic risk factors (0 vs. 1-3), and liver metastases (yes vs. no).
Maltese: Randomisation ġiet stratifikata skont il-kimoterapija (vinflunine vs. taxane), l-istat ta' espressjoni ta' PD-L1 f'IC (< 5% vs. ≥ 5%), in-numru ta' fatturi ta' riskju pronjostiċi (0 vs. 1-3), u metastasi fil-fwied (iva vs. le).
English: Grade 4 or recurrent Grade 3
Maltese: Mijosite rikorrenti ta' Grad 4 jew Grad 3
English: LIST OF EXCIPIENTS Excipients: L-histidine, glacial acetic acid, sucrose, polysorbate 20, water for injections
Maltese: L-histidine, glacial acetic acid, sucrose, polysorbate 20, ilma għall-injezzjonijiet
English: • allergic reaction (infusion-related reaction, hypersensitivity or anaphylaxis)
Maltese: • reazzjoni allerġika (reazzjoni relatata mal-infużjoni, sensittività eċċessiva jew anafilassi)
English: Kaplan-Meier curves for OS and PFS are presented in Figures 12 and 13.
Maltese: Kaplan-Meier għal OS u PFS huma ppreżentati fil-Figuri 12 u 13.
English: Only a few patients had severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2; n=8) (see section 4.2).
Maltese: Ftit pazjenti biss kellhom indeboliment sever tal-kliewi (eGFR 15 sa 29 mL/min/1.73 m2; n=8) (ara sezzjoni 4.2).
English: Tecentriq in combination therapy
Maltese: Tecentriq f'terapija kombinata
English: From the PD-L1+/BRCA1/2 mutant subgroup, 19 patients received atezolizumab plus nabpaclitaxel and 26 placebo plus nab-paclitaxel.
Maltese: Mis-sottogrupp b'PD-L1+/mutazzjoni ta' BRCA1/2, 19-il pazjent irċevew atezolizumab flimkien ma' nab-paclitaxel u 26 plaċebo flimkien ma' nab-paclitaxel.
English: In the IMpassion130 study, of the 614 patients tested, 89 (15%) carried pathogenic BRCA1/2 mutations.
Maltese: Fl-istudju IMpassion130, mis-614-il pazjent ittestjati, 89 (15%) kellhom mutazzjonijiet BRCA1/2 patoġeniċi.
English: IMpower150 after several cases of fatal pulmonary haemorrhage were observed, which is a known risk factor of treatment with bevacizumab.
Maltese: IMpower150 wara li ġew osservati diversi każijiet ta' emorraġija pulmonari fatali, li hija fattur ta' riskju magħruf ta' trattament b'bevacizumab.
English: No clinical data are available on the possible effects of atezolizumab on fertility.
Maltese: M'hemmx data klinika disponibbli dwar l-effetti possibbli ta' atezolizumab fuq il-fertilità.
English: The primary efficacy endpoint for IMvigor211 is overall survival (OS).
Maltese: Il-punt finali primarju tal-effikaċja għal IMvigor211 kien sopravivenza globali (OS - overall survival).
English: Atezolizumab in combination therapy
Maltese: Atezolizumab f'terapija kombinata
English: The systemic accumulation in area under the curve, maximum concentration and trough concentration was 1.91, 1.46 and 2.75-fold, respectively.
Maltese: L-akkumulazzjoni sistemika fl-erja taħt il-kurva, ilkonċentrazzjoni massima u l-konċentrazzjoni l-aktar baxxa kienu 1.91, 1.46 u 2.75 darba, rispettivament.
English: • The other ingredients are L-histidine, glacial acetic acid, sucrose, polysorbate 20 and water for injections.
Maltese: • Is-sustanzi l-oħra huma L-histidine, glacial acetic acid, sucrose, polysorbate 20 u ilma għallinjezzjonijiet.
English: • have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C
Maltese: • għandek jew kellek infezzjoni virali kronika tal-fwied, inklużi epatite B (HBV) jew epatite Ċ
English: Cohort 1 included 45 patients (38%) with ECOG performance status of 0, 50 patients (42%) with ECOG performance status of 1 and 24 patients (20%) with ECOG performance status of 2, 35 patients (29%) with no Bajorin risk factors (ECOG performance status ≥ 2 and visceral metastasis), 66 patients (56%) with one Bajorin risk factor and 18 patients (15 %) with two Bajorin risk factors, 84 patients (71%) with impaired renal function (glomerular filtration rate [GFR] < 60 mL/min), and 25 patients (21%) with liver metastasis.
Maltese: Koorti 1 inkluda 45 pazjent (38%) bi stat ta' eżekuzzjoni ta' ECOG ta' 0, 50 pazjent (42%) bi stat ta' eżekuzzjoni ta' ECOG ta' 1 u 24 pazjent (20%) bi stat ta' eżekuzzjoni ta' ECOG ta' 2, 35 pazjent (29%) bl-ebda fattur ta' riskju Bajorin (stat ta' eżekuzzjoni ta' ECOG ta' ≥ 2 u metastasi fil-vixxri), 66 pazjent (56%) b'fattur ta' riskju Bajorin wieħed u 18-il pazjent (15 %) b'żewġ fatturi ta' riskju Bajorin, 84 pazjent (71%) b'funzjoni renali indebolita (rata ta' filtrazzjoni mill-glomeruli
English: Patients were randomised to receive atezolizumab 840 mg or placebo by intravenous infusions on days 1 and 15 of every 28-day cycle, plus nab-paclitaxel (100 mg/m2) administered via intravenous infusion on days 1, 8 and 15 of every 28-day cycle.
Maltese: Il-pazjenti kienu randomised biex jirċievu atezolizumab 840 mg jew plaċebo permezz ta' infużjonijiet fil-vini fil-jiem 1 u 15 ta' kull ċiklu ta' 28 jum, flimkien ma' nab-paclitaxel (100 mg/m2) mogħti permezz ta' infużjoni fil-vini fil-jiem 1, 8 u 15 ta' kull ċiklu ta' 28 jum.
English: Across multiple phase III studies, 13.1% to 36.4% of patients developed treatment-emergent anti-drug antibodies (ADAs).
Maltese: III, 13.1% sa 36.4% tal-pazjenti żviluppaw antikorpi kontra l-mediċina (ADAs - anti-drug antibodies) li żviluppaw mat-trattament.
English: • overactive thyroid gland (hyperthyroidism)
Maltese: • glandola tat-tirojde attiva żżejjed (ipertirojdiżmu)
English: Investigator-assessed DOR (RECIST 1.1)** ^
Maltese: DOR stmat mill-investigatur (RECIST 1.1) ** ^
English: Myocarditis occurred in < 0.1% (2/8,000) of patients across all atezolizumab clinical trials in multiple tumour types and treatment combinations.
Maltese: Mijokardite seħħet f'< 0.1% (2/8,000) tal-pazjenti fil-provi kliniċi kollha b'atezolizumab f'diversi tipi ta' tumuri u kombinazzjonijiet ta' trattament.
English: A total of 902 patients were enrolled and stratified by presence of liver metastases, prior taxane treatment, and by PD-L1 expression status in tumour-infiltrating immune cells (IC) (PD-L1 stained tumour-infiltrating immune cells [IC] <1% of tumour area vs. ≥ 1% of the tumour area) assessed by the VENTANA PD-L1 (SP142) Assay.
Maltese: Total ta' 902 pazjenti kienu rreġistrati u stratifikati skont il-preżenza ta' metastasi fil-fwied, trattament b'taxane minn qabel, u skont l-istat ta' espressjoni ta' PD-L1 f'ċelluli immuni (IC - immune cells) li jinfiltraw it-tumur (ċelluli immuni [IC] imtebba' b'PD-L1 li jinfiltraw it-tumur < 1% tal-erja tat-tumur vs. ≥ 1% tal-erja tat-tumur) evalwati permezz tal-Analiżi VENTANA PD-L1 (SP142).
English: Arm B (Placebo + carboplatin + etoposide)
Maltese: Grupp B (Plaċebo + carboplatin + etoposide)
English: Tecentriq monotherapy
Maltese: Tecentriq bħala monoterapija
English: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis and type 1 diabetes mellitus, including diabetic ketoacidosis have been observed in clinical trials with atezolizumab (see section
Maltese: Ipotirojdiżmu, ipertirojdiżmu, insuffiċjenza adrenali, ipofisite u dijabete mellitus tat-tip 1, inkluż ketoaċidożi dijabetika kienu osservati fi provi kliniċi b'atezolizumab (ara sezzjoni 4.8).
English: • Stop your treatment with Tecentriq.
Maltese: • Iwaqqaf it-trattament tiegħek b'Tecentriq.
English: Includes reports of diarrhoea, defaecation urgency, frequent bowel movements, gastrointestinal hypermotility.
Maltese: Tinkludi rapporti ta' dijarea, ippurgar urġenti, ippurgar frekwenti, ipermotilità gastrointestinali.
English: Tecentriq 840 mg concentrate for solution for infusion atezolizumab
Maltese: Tecentriq 840 mg konċentrat għal soluzzjoni għall-infużjoni atezolizumab
English: A population pharmacokinetic analysis indicates that central compartment volume of distribution is 3.28 L and volume at steady-state is 6.91 L in the typical patient.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tindika li l-volum ta' distribuzzjoni tal-kompartiment ċentrali huwa 3.28 L u l-volum fi stat fiss huwa 6.91 L fil-pazjent tipiku.
English: Blood and lymphatic system disorders Very common anaemia, thrombocytopeniac, neutropeniad, leukopeniae
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni ħafna anemija, tromboċitopenijac, newtropenijad, lewkopenijae
English: Myasthenic syndrome
Maltese: Kolite Sintomatika
English: 1-year OS rate (%)
Maltese: Rata OS ta' sena (%)
English: The majority of patients had a baseline ECOG performance status of 1 (59%) and PDL1 expression <1% (approximately 52%).
Maltese: Il-maġġoranza tal-pazjenti kellhom stat ta' eżekuzzjoni ta' ECOG fil-linja bażi ta' 1 (59%) u espressjoni ta' PD-L1 ta' <1% (madwar 52%).
English: Arm B Nab-paclitaxel + carboplatin
Maltese: Grupp B Nab-paclitaxel + carboplatin
English: Immune-related meningoencephalitis
Maltese: Meningoenċefalite relatata mal-immunità
English: Table 6: Summary of updated efficacy in the ITT population (IMpower150) Efficacy endpoint
Maltese: Tabella 6: Sommarju ta' effikaċja aġġornata fil-popolazzjoni ITT (IMpower150) Punt finali tal-effikaċja
English: Baseline ECOG performance status was 0 (45.6%) or 1 (54.4%).
Maltese: L-istat ta' eżekuzzjoni ta' ECOG fil-linja bażi kien ta' 0 (45.6%) jew 1 (54.4%).
English: PD-L1 expression of ≥ 5% in IC
Maltese: Espressjoni ta' PD-L1 ta' ≥ 5% f'IC
English: Primary efficacy endpoint OS*
Maltese: Punt finali primarju tal-effikaċja OS*
English: Grenzacherstrasse 124
Maltese: Hoffmann-La Roche AG Grenzacherstrasse 124 4070 Basel
English: 1 vial
Maltese: Koorti 1)
English: After dilution, one mL of solution should contain approximately 4.4 mg of Tecentriq (1,200 mg/270 mL).
Maltese: Wara d-dilwizzjoni, mL wieħed ta' soluzzjoni għandu jkun fih bejn wieħed u ieħor 4.4 mg ta' Tecentriq (1,200 mg/270 mL).
English: Table 6 - Summary of efficacy in patients with PD-L1 expression ≥1% (IMpassion130) Key efficacy endpoints
Maltese: Tabella 6 - Sommarju tal-effikaċja f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1% (IMpassion130) Punti finali ewlenin tal-effikaċja
English: • type 1 diabetes
Maltese: • dijabete tip 1
English: The safety and efficacy of Tecentriq in children and adolescents aged below 18 years have not been established.
Maltese: Is-sigurtà u effikaċja ta' Tecentriq fi tfal u adolexxenti ta' età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Immune-related endocrinopathies Thyroid disorders
Maltese: Endokrinopatiji relatati mal-immunità Disturbi fit-tirojde
English: Patients with liver metastases did not show improved PFS or OS with atezolizumab, nab-paclitaxel and carboplatin, compared to nab-paclitaxel and carboplatin (HR of 0.93, 95% CI: 0.59, 1.47 for PFS and HR of 1.04,
Maltese: Il-pazjenti b'metastasi fil-fwied ma wrewx PFS jew OS imtejba b'atezolizumab, nab-paclitaxel u carboplatin, meta mqabbla ma' nab-paclitaxel u carboplatin (HR ta' 0.93, CI ta' 95%: 0.59, 1.47 għal PFS u HR ta' 1.04, CI ta' 95%: 0.63, 1.72 għal OS, rispettivament).
English: Figure 7: Forest plot of overall survival by PD-L1 expression (IMpower130)
Maltese: Figura 7: Forest plot ta' sopravivenza globali skont l-espressjoni ta' PD-L1 (IMpower130)
English: Permanently discontinue Tecentriq
Maltese: Waqqaf Tecentriq b'mod permanenti
English: The median duration was 16.8 months (range: 0 day to 16.8 months).
Maltese: It-tul ta' żmien medjan kien ta' 16.8 xhur (medda: 0 jiem sa 16.8 xhur).
English: (hypoxia)
Maltese: (tromboċitopenija)
English: Tecentriq is used to treat adults with:
Maltese: Tecentriq jintuża biex jittratta adulti:
English: Patients excluded from clinical trials
Maltese: Pazjenti esklużi minn provi kliniċi