FrancophonIA/ELRC3.0 huggingface dataset:
English: Microcrystalline cellulose Low-substituted hydroxypropyl cellulose Sodium stearyl fumarate
Maltese: Microcrystalline cellulose Hydroxypropyl cellulose b'sostituzzjoni baxxa Sodium stearyl fumarate
English: The absolute bioavailability of TAGRISSO is 70% (90% CI 67, 73).
Maltese: Il-bijodisponibbiltà assoluta ta' TAGRISSO hi ta' 70 % (90 % CI 67, 73).
English: Common (3.9%)
Maltese: Komuni 3.9 %)
English: Number of Events (62% maturity)
Maltese: Numru ta' Avvenimenti (62 % maturità)
English: Osimertinib is a Tyrosine Kinase Inhibitor (TKI).
Maltese: Osimertinib huwa Inibitur ta' Tyrosine Kinase (Tyrosine Kinase Inhibitor, TKI).
English: Reproductive toxicity
Maltese: Tossiċità fis-sistema riproduttiva
English: Further catalyzing enzymes have not been identified.
Maltese: Ma ġewx identifikati aktar enzimi katalizzaturi.
English: (AUC increase by 6% (90% CI -5, 19) and Cmax decrease by 7% (90% CI -19, 6)).
Maltese: (Żieda fl-AUC ta' 6% (90% CI -5, 19) u tnaqqis fis-Cmax ta' 7% (90% CI -19, 6)).
English: • you are taking St. John's Wort (Hypericum perforatum).
Maltese: • jekk inti qed tieħu St.John's Wort (Hypericum perforatum)
English: • Rifabutin or rifampicin - used for tuberculosis (TB).
Maltese: • Rifabutin jew rifampicin - li jintużaw għal tuberkolożi (TB).
English: 5 CTCAE grade 5 events (fatal) were reported.
Maltese: Avvenimenti ta' grad 5 ta' CTCAE (fatali) kienu rrapportati.
English: Discontinue TAGRISSO (see Section 4.4)
Maltese: Waqqaf TAGRISSO (ara Sezzjoni 4.4)
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjonitar-riskju(RMP)
English: • The other ingredients are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, black iron oxide (see section 2 “Information on other ingredients in this medicine”).
Maltese: • L-ingredjenti l-oħrajn huma mannitol, microcrystalline cellulose, hydroxypropyl cellulose b'sostituzzjoni baxxa, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red ironoxide, black iron oxide (ara sezzjoni 2 “Informazzjoni dwar sustanzi mhux attivi oħra f'din il-mediċina”).
English: Date of first authorisation: 2 February 2016 Date of latest renewal: 12 December 2016
Maltese: Data tal-aħħar tiġdid: 12 ta' Diċembru 2016
English: Discontinuation due to adverse reactions was 4.3%.
Maltese: It-twaqqif minħabba reazzjonijiet avversi kien ta' 4.3%.
English: HR=Hazard Ratio; CI=Confidence Interval, NC=Not Calculable A HR< 1 favours TAGRISSO, an Odds ratio of >1 favours TAGRISSO
Maltese: HR=Proporzjon ta' Periklu; CI=Intervall ta' Kunfidenza, NC=Ma jistax jiġi Kkalkulat HR< 1 jiffavorixxi TAGRISSO, proporzjon ta' Probabbiltà ta' >1 jiffavorixxi TAGRISSO
English: Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin)
Maltese: Kimoterapija (Pemetrexed/Cisplatin jew Pemetrexed/Carboplatin)
English: • The active substance is osimertinib (as mesylate).
Maltese: • Is-sustanza attiva hija osimertinib (bħala mesylate).
English: Effects of osimertinib on P-gp and BCRP
Maltese: L-effetti ta' osimertinib fuq P-gp u BCRP
English: • you have ever had heart problems - your doctor may want to keep a close eye on you.
Maltese: • qatt kellek problemi bil-qalb -it-tabib tiegħek jaf ikun irid josservak mill-qrib.
English: Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) (N=140)
Maltese: (Pemetrexed/Cisplatin jew Pemetrexed/Carboplatin) (N=140)
English: Cardiac QTc interval greater than 500 msec on at least 2 separate ECGs
Maltese: Kardijaku Intervall QTc ta' iktar minn 500 msec f'tal-inqas 2 ECGs separati
English: EGFR TKI comparator (gefitinib or erlotinib) N=67
Maltese: Komparatur EGFR TKI (gefitinib jew erlotinib) N=67
English: In vitro, osimertinib does not inhibit OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 and MATE2K at clinically relevant concentrations.
Maltese: In vitro, osimertinib ma jinibixxix P-glycoprotein, OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 u MATE2K f'konċentrazzjonijiet klinikament relevanti.
English: Based on in vitro studies, osimertinib is a competitive inhibitor of CYP 3A4/5 but not CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 and 2E1 at clinically relevant concentrations.
Maltese: Abbażi ta' studji in vitro, osimertinib huwa inibitur kompetittiv ta' CYP 3A4/5 iżda mhux ta' CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 u 2E1 f'konċentrazzjonijiet klinikament rilevanti.
English: Osimertinib may increase the exposure of breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) substrates.
Maltese: Osimertinib jista' jżid lespożizzjoni tas-sottostrati ta' proteina reżistenti għall-kanċer tas-sider (BCRP) u ta' P-glycoprotein (P-gp).
English: EGFR TKI comparator (gefitinib or erlotinib) (N=277)
Maltese: Komparatur EGFR TKI (gefitinib jew erlotinib) (N=277)
English: The types of adverse events reported were similar regardless of age.
Maltese: It-tipi ta' reazzjonijiet avversi rrappurtati kienu simili irrispettivment mill-età.
English: • Efavirenz and etravirine - used to treat HIV infections/AIDS.
Maltese: • Efavirenz u etravirine -użati biex jikkuraw infezzjonijiet tal-HIV/AIDS.
English: Randomisation was stratified by EGFR mutation type (Ex19del or L858R) and ethnicity (Asian or non-Asian).
Maltese: Ir-randomizzazzjoni ġiet stratifikata skont it-tip ta' mutazzjoni EGFR (Ex19del jew L858R) u l-etniċità (Asjatiċi jew mhux Asjatiċi).
English: Haematological events
Maltese: Avvenimenti ematoloġiċi
English: Cartons of 30 x 1 tablets (3 blisters).
Maltese: Kartun ta' 30 x 1 pillola (3 folji).
English: Dry skin
Maltese: Kimotera pija
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE35.
Maltese: Kategorija farmakoterapewtika: aġenti anti-neoplastiċi, inibituri ta' protein kinase, Kodiċi ATC:
English: Number of Events (% maturity)
Maltese: Numru ta' Avvenimenti (% maturità)
English: Grade 3 and Grade 4 adverse reactions across both studies were 9.7% and 0.9%, respectively.
Maltese: Avvenimenti avversi ta' Grad 3 u Grad 4 fiż-żewġ studji kienu ta' 9.7% u 0.9%, rispettivament.
English: Cartons of 28 x 1 tablets (4 blisters).
Maltese: Kartun ta' 28 x 1 pillola (4 folji).
English: A CNS ORR of 54% (27/50 patients; 95% CI: 39.3, 68.2) was observed with 12% of these responses being complete responses.
Maltese: Ġie osservat ORR tas-CNS ta' 54 % (27/50 pazjent; 95 % CI: 39.3, 68.2) b'12 % ta' dawn irrisponsi li kienu risponsi kompleti.
English: Patient Reported Outcomes (PRO)
Maltese: Ir-Riżultati Rrappurtati mill-Pazjenti (PRO, Patient Reported Outcomes)
English: Very common (67%) 7.2%
Maltese: Komuni ħafna (67%) 7.2 %
English: CNS response rate % (n/N) (95% CI)
Maltese: Rata ta' rispons ta' CNS % (n/N) (95 % CI)
English: The median PFS was 11.0 months 95% CI (9.6, 12.4).
Maltese: IlPFS medjana kienet ta' 11.0-il xahar 95% CI (9.6, 12.4).
English: In the 411 pre-treated EGFR T790M mutation-positive patients, the total ORR by Blinded Independent Central Review (BICR) was 66% (95% CI: 61, 71).
Maltese: Fl-411-il pazjent pożittivi għal mutazzjoni T790M ta' EFGR ikkurati minn qabel, it-total mirReviżjoni Ċentrali Indipendenti Blinded (BICR) kien ta' 66 % (95 % CI: 61, 71).
English: Population estimated mean volume of distribution at steady-state (Vss/F) of osimertinib is 918 L indicating extensive distribution into tissue.
Maltese: Il-valur medju stmat tal-popolazzjoni tad-distribuzzjoni fi stat fiss (Vss/F) ta' osimertinib huwa ta' 918 L li jindika distribuzzjoni estensiva fit-tessut.
English: CNS efficacy by RECIST v1.1 in FLAURA demonstrated a nominal statistically significant improvement in CNS PFS (HR=0.48, 95% CI 0.26, 0.86; P=0.014).
Maltese: L-effikaċja ta' CNS permezz ta' RECIST v1.1 f'FLAURA uriet titjib statistikament sinifikanti nominali fil-PFS tas-CNS (HR=0.48, 95% CI 0.26, 0.86; P=0.014).
English: In vitro plasma protein binding of osimertinib is 94.7% (5.3% free).
Maltese: In vitro, it-twaħħil tal-proteina mal-plażma ta' osimertinib huwa 94.7 % (5.3 % ħieles).
English: A pharmacokinetic/pharmacodynamic analysis predicted a drug-related QTc interval prolongation at 80 mg of 14 msec with an upper bound of 16 msec (90% CI).
Maltese: Analiżi farmakokinetika/farmakodinamika bassret titwil fl-intervall QTc relatat mal-mediċina f'80 mg ta' 14 msec b'limitu massimu ta' 16 msec (90% CI).
English: TAGRISSO is supplied in blisters containing 28 x 1 film-coated tablets, packed in cartons containing 4 blisters of 7 tablets each.
Maltese: TAGRISSO jiġi f'folji li fihom 28 x 1 pillola, ippakkjati f'kartun li fihom 4 folji ta' 7 pilloli kull waħda.
English: Adverse reactions have been assigned to the frequency categories in Table 2 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the 1142 EGFR mutation positive NSCLC patients who received TAGRISSO at a dose of 80 mg daily in the FLAURA, AURA3, AURAex, AURA 2 and AURA1 studies.
Maltese: Ir-reazzjonijiet avversi ġew assenjati lill-kategoriji ta' frekwenza f'Tabella 2 u fejn possibbli, ġew ibbażati fuq l-inċidenza ta' avvenimenti avversi komparabbli rrapportati f'sett ta' dejta miġbur mill1142 pazjent b'NSCLC pożittiv għall-mutazzjoni EGFR li rċevew TAGRISSO f'doża ta' 80 mg kuljum fl-istudji FLAURA, AURA3, AURAex, AURA 2 u AURA1.
English: TAGRISSO is supplied in blisters containing 30 x 1 film-coated tablets, packed in cartons containing 3 blisters of 10 tablets each.
Maltese: TAGRISSO jiġi f'folji li fihom 30 x 1 pillola, ippakkjati f'kartun li fihom 3 folji ta' 10 pilloli kull waħda.
English: Similarly, the exposure to metabolite AZ5104 decreased by 82% for the AUC and 78% for Cmax.
Maltese: Bl-istess mod, l-espożizzjoni għallmetabolit AZ5104 naqset bi 82% għall-AUC u 78% għas-Cmax.
English: Paronychia
Maltese: Paronikja
English: Clinical PK interactions with CYP3A4 substrates are unlikely.
Maltese: Interazzjonijiet kliniċi PK ma' sottostrati ta' CYP3A4 mhumiex probabbli.
English: The geometric mean ratio (90% CI) of osimertinib AUC and Cmax was 63.3% (47.3, 84.5) and 51.4% (36.6, 72.3) in patients with mild hepatic impairment and 68.4% (49.6, 94.2) and 60.7% (41.6, 88.6) in patients with moderate hepatic impairment; for the metabolite AZ5104 the AUC and Cmax were 66.5% (43.4, 101.9) and 66.3% (45.3, 96.9) in patients with mild hepatic impairment and 50.9% (31.7, 81.6) and 44.0% (28.9, 67.1) in patients with moderate hepatic impairment, compared to the exposure in patients with normal hepatic function.
Maltese: Il-proporzjon medju ġeometriku (90% CI) tal-AUC u tas-Cmax ta' osimertinib kien 63.3 % (47.3, 84.5) u 51.4 % (36.6, 72.3) f'pazjenti b'indeboliment ħafif tal-fwied u 68.4 % (49.6, 94.2) u 60.7 % (41.6, 88.6) f'pazjenti b'indeboliment moderat tal-fwied; għall-metabolit AZ5104, l-AUC u s-Cmax kienu 66.5 % (43.4, 101.9) u 66.3 % (45.3, 96.9) f'pazjenti b'indeboliment moderat tal-fwied u 50.9 % (31.7, 81.6) u 44.0 % (28.9, 67.1) f'pazjenti b'indeboliment moderat talfwied, meta mqabbel mal-espożizzjoni f'pazjenti b'funzjoni normali tal-fwied.
English: Very common (49%) 1.2%
Maltese: Komuni ħafna (49 %) 1.2 %
English: A risk for decreased exposure of hormonal contraceptives cannot be excluded.
Maltese: Riskju għal esponiment imnaqqas ta' kontraċettivi ormonali ma jistax jiġi eskluż.
English: Based on in vitro studies, 2 pharmacologically active metabolites (AZ7550 and AZ5104) have subsequently been identified in the plasma of preclinical species and in humans after oral dosing with osimertinib; AZ7550 showed a similar pharmacological profile to TAGRISSO while AZ5104 showed greater potency across both mutant and wild-type EGFR.
Maltese: Abbażi ta' studji in vitro , 2 metaboliti farmakoloġikament attivi (AZ7550 u AZ5104) ġew sussegwentement identifikati fil-plażma tal-ispeċijiet u l-bnedmin ta' qabel l-użu kliniku wara dożi orali b'osimertinib; AZ7550 wera profil farmakoloġikament simili għal TAGRISSO filwaqt AZ5104 wera potenza ikbar kemm fl-EFGR tal-mutazzjoni kif ukoll f'dik wild-type.
English: Very common (68%) 1.5%
Maltese: Komuni ħafna (68 %) 1.5 %
English: In a clinical Pregnane X Receptor (PXR) interaction study, co-administration of TAGRISSO with fexofenadine (P-gp substrate) increased the AUC and Cmax of fexofenadine by 56% (90% CI 35, 79) and 76% (90% CI 49, 108) after a single dose and 27% (90% CI 11, 46) and 25% (90% CI 6, 48) at steady state, respectively.
Maltese: Fi studju ta' interazzjoni klinika ta' Pregnane X Receptor (PXR), l-għoti flimkien ta' TAGRISSO ma' fexofenadine (sottostrat ta' P-gp) żied l-AUC u s-Cmax ta' fexofenadine b'56 % (90% CI 35, 79) u b'76 % (90% CI 49, 108) wara doża waħda u b'27 % (90% CI 11, 46) u b'25 % (90% CI 6, 48) fi stat fiss, rispettivament.
English: Based on a population pharmacokinetic analysis of 593 patients with mild renal impairment (CLcr 60 to less than 90 mL/min), 254 patients with moderate renal impairment (CLcr 30 to <than 60 mL/min), 5 patients with severe renal impairment (CLcr 15 to <than 30 mL/min) and 502 patients with normal renal function (greater than or equal to 90 mL/min), osimertinib exposures were similar.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni ta' 593 pazjent b'indeboliment tal-kliewi ħafif (CLcr 60 għal inqas minn 90 mL/min), 254 pazjenti b'indeboliment tal-kliewi moderat (CLcr 30 għal <minn 60 mL/min), 5 pazjenti b'indeboliment tal-kliewi sever (CLcr 15 sa <minn 30 mL/min) u 502 pazjenti b'funzjoni tal-kliewi normali (iktar minn jew daqs 90 mL/min), l-espożizzjonijiet ta' osimertinib kienu simili.
English: No QTcrelated arrhythmias were reported in the FLAURA or AURA studies (see sections 4.4 and 5.1).
Maltese: Ma ġiet irrapportata l-ebda aritmija relatata mal-QTc fl-istudji AURA (ara sezzjonijiet 4.4 u 5.1).
English: Adverse reactions are listed according to system organ class (SOC) in MedDRA.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi (SOC) f'MedDRA.
English: Other medicines and TAGRISSO
Maltese: MEDIĊINI OĦRA U TAGRISSO
English: Interactions with transport proteins
Maltese: Interazzjonijiet mal-proteini ta' trasport
English: Represents the incidence of laboratory findings, not of reported adverse events.
Maltese: Tirrappreżenta l-inċidenza ta' sejbiet fil-laboratorju, mhux ta' avvenimenti avversi rrapportati.
English: Includes cases reported within the clustered terms for rash AEs: Rash, rash generalised, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, drug eruption, skin erosion.
Maltese: Raxx, raxx ġeneralizzat, raxx eritematuż, raxx makulari, raxx makulo-papulari, raxx papulari, raxx bil-ponot, raxx pruritiku, raxx vesikulari, raxx follikulari, eritema, follikulite, akne, dermatite u dermatite akneiforma, ħruġ ta' raxx mil-mediċina, erużjoni tal-ġilda.
English: Chemotherapy consisted of pemetrexed 500 mg/m2 with carboplatin AUC5 or pemetrexed 500 mg/m2 with cisplatin 75 mg/m2 on Day 1 of every 21-day cycle for up to 6 cycles.
Maltese: 500 mg/m2 bi cisplatin 75 mg/m2 f'Jum 1 ta' kull ċiklu ta' 21 jum sa 6 ċikli.
English: See also Section 2.
Maltese: Ara wkoll Sezzjoni 2.
English: Thirty-one percent (31%) (N=129) had received 1 prior line of therapy (EGFR-TKI treatment only), 69% (N=282) had received 2 or more prior lines.
Maltese: Wieħed u tletin fil-mija (31%) (N=129) irċevew linja ta' terapija preċedenti waħda (kura ta' EGFR-TKI biss), 69% (N=282) kienu rċevew 2 linji preċedenti qabel jew iktar.
English: A sensitivity analysis of PFS was conducted by a Blinded Independent Central Review (BICR) and showed a median PFS of 11.0 months with TAGRISSO compared with 4.2 months with chemotherapy.
Maltese: Ċentrali Indipendenti Blinded (BICR, Blinded Independent Central Review) u wriet PFS medjana ta' 11.0 xhur b'TAGRISSO meta mqabbel ma' 4.2 xhur bil-kimoterapija.
English: Number of responses (n), Response Rate (95% CI)
Maltese: Numru ta' risponsi (n), Rata ta' Rispons (95 % CI)
English: The baseline demographic and disease characteristics of the overall study population were: median age 64 years (range 26-93 years), ≥75 years old (14%), female (63%), White (36%), Asian (62%), never smokers (64%), World Health Organization (WHO) performance status of 0 or 1 (100%), metastatic bone disease (36%), extra-thoracic visceral metastases (35%), CNS metastases (21%, identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases).
Maltese: Il-karatteristiċi demografiċi u tal-marda fil-linja bażi tal-popolazzjoni globali tal-istudju kienu: età medjana ta' 64 sena (medda 26-93 sena), ≥75 sena (14 %), nisa (63 %),Bojod (36 %), Asjatiċi (62 %), qatt ma pejpu (64 %), status ta' prestazzjoni tal-Organizzazzjoni Dinjija tas-Saħħa 0 jew 1 (100 %), marda tal-għadam metastatika (36 %), metastasi vixxerali estratorariċi (35 %), metastasi ta' CNS (21 %, identifikati mis-sit ta' leżjoni CNS fil-linja bażi, storja medika, u/jew qabel il-kirurġija, u/jew qabel ir-radjoterapija għall-metastasi ta' CNS).
English: Very common (54%) 1.6%
Maltese: Komuni ħafna (54%) 1.6 %
English: 30 x 1 film-coated tablets 28 x 1 film-coated tablets
Maltese: 30 x 1 pillola miksijin b'rita 28 x 1 pillola miksijin b'rita
English: Both metabolites appeared slowly in plasma after administration of TAGRISSO to patients, with a median (min-max) tmax of 24 (4-72) and 24 (6-72) hours, respectively.
Maltese: Iż-żewġ metaboliti dehru bil-mod fil-plażma wara l-għoti ta' TAGRISSO lill-pazjenti, b'tmax medjan (minmass) ta' 24 (4-72) u 24 (6-72) siegħa, rispettivament.
English: In FLAURA and AURA3 (N=1142), 43% of patients were 65 years of age and older, and 13% were 75 years of age and older.
Maltese: F'FLAURA u AURA3 (N=1142), 43 % tal-pazjenti kellhom 65 sena jew iktar, li 15u 13 % kellhom 75 sena jew iktar.
English: In vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against EGFR across a range of all clinically relevant EGFR sensitising-mutant and T790M mutant non-small cell lung cancer (NSCLC) cell lines (apparent IC50s from 6 nM to 54 nM against phospho-EGFR).
Maltese: Studji in vitro wrew li osimertinib għandu attività qawwija u inibitorja għolja kontra EGFR fil-medda ta' linji ta' ċelloli kollha ta' kanċer tal-pulmun ta' ċelloli mhux żgħar (NSCLC) b'mutazzjoni T790M u mutazzjoni sensitizzanti tal-EGFR klinikament rilevanti (IC50s evidenti minn 6 nM sa 54 nM kontra phospho-EGFR).
English: In a clinical PK study, co-administration of TAGRISSO with simvastatin (sensitive CYP3A4 substrate) decreased the AUC and Cmax of simvastatin by 9% and 23% respectively.
Maltese: Fi studju kliniku PK, l-għoti flimkien ta' TAGRISSO ma' simvastatin (sottostrat sensittiv ta' CYP3A4) naqqas l-AUC u s-Cmax ta' simvastatin b'9% u 23% rispettivament.
English: In a clinical trial, patients with different types of advanced solid tumours and with mild hepatic impairment (Child Pugh A, mean score = 5.3, n=7) or moderate hepatic impairment (Child Pugh B, mean score = 8.2, n=5) had no increase in exposure compared to patients with normal hepatic function (n=10) after a single 80 mg dose of TAGRISSO.
Maltese: Fi prova klinika, pazjenti b'tipi differenti ta' tumuri solidi avvanzati u b'indeboliment ħafif tal-fwied (Child Pugh A, punteġġ medju = 5.3, n=7) jew b'indeboliment moderat tal-fwied (Child Pugh B, punteġġ medju = 8.2, n=5) ma kellhom l-ebda żieda fl-espożizzjoni meta mqabbel ma' pazjenti b'funzjoni normali tal-fwied (n=10) wara doża waħda ta' 80 mg ta' TAGRISSO.
English: The most commonly reported adverse drug reactions (ADRs) were diarrhoea (49%) and rash (47%).
Maltese: L-iktar reazzjonijiet avversi għall-mediċina rrapportati b'mod komuni (ADRs) kienu dijarea (49%) u raxx (47%).
English: Very common (35%) 4.1%
Maltese: Komuni ħafna (35 %) 4.1 %
English: Similarly, based on population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) >ULN or total bilirubin >1.0 to 1.5x ULN and any AST) or moderate hepatic impairment (total bilirubin between 1.5 to 3 times ULN and any AST).
Maltese: B'mod simili, abbażi ta' analiżi farmakokinetika tal-popolazzjoni, l-ebda aġġustament fid-doża mhuwa rrakkomandat f'pazjenti b'indeboliment tal-fwied ħafif (bilirubina <limitu ta' fuq tan-normal (ULN) u aspartate aminotransferase (AST) >ULN jew bilirubina totali >1.0 sa 1.5x ULN u kwalunkwe AST) jew indeboliment tal-fwied moderat (bilirubin totali bejn 1.5 sa 3 darbiet ULN u kwalunkwe AST).
English: Based on in vitro studies, osimertinib is not an inhibitor of UGT1A1 and UGT2B7 at clinically relevant concentrations hepatically.
Maltese: Abbażi ta' studji in vitro, osimertinib mhuwiex inibitur ta' UGT1A1 u UGT2B7 f'konċentrazzjonijiet klinikament rilevanti fil-fwied.
English: Pregnancy - information for men
Maltese: Tqala - Informazzjoni għan-nisa
English: In vitro studies indicate that osimertinib is metabolised predominantly by CYP3A4, and CYP3A5.
Maltese: Studji in vitro jindikaw li osimertinib huwa prinċipalment metabolizzat minn CYP3A4, u CYP3A5.
English: Patients were randomised 1:1 to receive either TAGRISSO (n=279, 80 mg orally once daily) or EGFR TKI comparator (n=277; gefitinib 250 mg orally once daily or erlotinib 150 mg orally once daily).
Maltese: Il-pazjenti ġew randomizzati fi 1:1 biex jirċievu jew TAGRISSO (n=279, 80 mg mill-ħalq darba kuljum) jew komparatur EGFR TKI (n=277; gefitinib 250 mg mill-ħalq darba kuljum jew erlotinib
English: Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Maltese: Waqqaf TAGRISSO għal kollox a Nota: L-intensità ta' avvenimenti klinikament avversi kklassifikata mill-verżjoni 4.0 tal-Kriterji tat-Terminoloġija Komuni għal Avvenimenti Avversi (Common Terminology Criteria for Adverse Events, CTCAE) tal-Istitut Nazzjonali tal-Kanċer (National Cancer Institute, NCI).
English: Based on population pharmacokinetic analysis, osimertinib apparent plasma clearance is 14.3 L/h, apparent volume of distribution is 918 L and terminal half-life of approximately 44 hours.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni, it-tneħħija mill-plażma evidenti ta' osimertinib hija ta' 14.3 L/h, il-volum ta' distribuzzjoni evidenti huwa ta' 918 L u half-life terminali ta' madwar 44 siegħa.
English: • Oral hormonal contraceptive pill- used to prevent pregnancy.
Maltese: • Pillola ta' kontraċezzjoni ormonali orali -użata għall-prevenzjoni tat-tqala.
English: Beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with “AZ” and “80” on one side and plain on the reverse.
Maltese: Pillola ta' kulur kafellatte, ta' 7.25 x 14.5 mm, ovali, bikonvessa, imnaqqxa b'"AZ" u "80" fuq naħa waħda u xejn fuq in-naħa l-oħra.
English: In addition, the corresponding frequency category for each adverse reaction is based on the CIOMS III convention and is defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Maltese: Barra minn hekk, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa hija bbażata fuq ilkonvenzjoni ta' CIOMS III u hija ddefinita bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħrufa (ma tistax tiġi stmata mid-dejta disponibbli).
English: Keratitis was reported in 0.7% (n=8) of the 1142 patients treated with TAGRISSO in the FLAURA and AURA studies.
Maltese: Il-keratite ġiet irrappurtata f'0.7 % (n=8) tal-1142pazjent ikkurati b'TAGRISSO fl-istudji FLAURA u AURA.
English: Number of deaths, (25% maturity)
Maltese: Numru ta' Mwiet (25 % maturità)
English: The incidence of ILD was 10.4% in patients of Japanese ethnicity, 1.8% in patients of Asian ethnicity and 2.8% in non-Asian patients (see section 4.8).
Maltese: 4% f'pazjenti ta' etniċità Ġappuniża, 1.8% f'pazjenti ta' etniċità Asjatika u 2.8% f'pazjenti mhux Asjatiċi (ara sezzjoni 4.8)