FrancophonIA/ELRC3.0 huggingface dataset:
English: Subgroup analysis indicated PFS benefit of olaparib versus comparator in TNBC (HR 0.43; 95% CI: 0.29-0.63, n=152) and HR+ (HR 0.82; 95% CI: 0.55-1.26, n=150) patient subgroups.
Maltese: Analiżi tas-sottogruppi indikat l-benefiċċju fil-PFS ta' olaparib kontra l-komparatur f'sottogruppi ta' pazjenti ta' TNBC (HR 0.43; 95% CI: 0.29-0.63, n=152) u HR+ (HR 0.82; 95% CI: 0.55-1.26, n=150).
English: Large rearrangements in the BRCA1/2 genes were detected in 5.5% (21/383) of the randomised patients.
Maltese: Ġew identifikati riarranġamenti kbar fil-ġeni BRCA1/2 f'5.5% (21/383) tal-pazjenti randomizzati.
English: PFS2 (65% maturity) - DCO 25 September 2017
Maltese: PFS2 (maturità ta' 65%) - DCO 25 ta' Settembru 2017
English: There are very limited data in patients with a somatic BRCA mutation.
Maltese: Hemm dejta limitata ħafna f'pazjenti b'mutazzjoni BRCA somatika.
English: There are no clinical data on fertility.
Maltese: M'hemm ebda data klinika dwar il-fertilità.
English: Embryofoetal toxicity
Maltese: Tossiċità embrijofetali
English: • Capsule shell: hypromellose, titanium dioxide (E171), gellan gum (E418), potassium acetate.
Maltese: • Qoxra tal-kapsula: Hypromellose, Titanium dioxide (E171), gomma tal-ġellan (E418), Potassium acetate.
English: Very common Anaemia Common Neutropenia a, Thrombocytopenia a,
Maltese: Komuni ħafna Anemija a, Newtropenja a, Tromboċitopenija a,
English: • cyclosporine, sirolimus, tacrolimus - used to suppress the immune system
Maltese: • cyclosporine, sirolimus, tacrolimus - użati sabiex irażżnu s-sistema immunitarja
English: • if you are breast-feeding (see section 2 below for more information).
Maltese: • jekk inti qed tredda' (ara sezzjoni 2 ta' hawn taħt għal aktar informazzjoni).
English: This medicinal product contains 0.24 mg sodium per 100 mg tablet and 0.35 mg sodium per 150 mg tablet, i.e. essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih 0.24 mg sodium f'kull pillola ta' 100 mg u 0.35 mg sodium f'kull pillola ta' 150 mg, jiġifieri huwa essenzjalment “ħieles mis-sodium”.
English: 56 film-coated tablets (7 blisters).
Maltese: 56 pillola miksija b'rita (7 folji).
English: Induction of CYP1A2, 2B6 and 3A4 has been shown in vitro with CYP2B6 being most likely to be induced to a clinically relevant extent.
Maltese: L-induzzjoni ta' CYP1A2, 2B6 u 3A4 intweriet in vitro b'CYP2B6 ikun l-aktar probabbli li jiġi indott b'mod klinikament rilevanti.
English: 0 Olaparib 300 mg bd 0 Placebo bd
Maltese: 2 0 Olaparib 300 mg bd 0 0 Plaċebo bd
English: There were 389 patients who were germline BRCA1/2m and 2 who were somatic BRCA1/2m in SOLO1.
Maltese: Kien hemm 389 pazjent li kienu BRCA1/2m tal-linja ġerminali u 2 li kienu BRCA1/2m somatiċi f'SOLO1.
English: OUTER CARTON MULTIPACK -including the blue box
Maltese: KARTUNA TA' BARRA PAKKETT MULTIPLU - inkluż il-kaxxa l-blu
English: In normal cells, homologous recombination repair (HRR), which requires functional BRCA1 and 2 genes, is effective at repairing these DNA DSBs.
Maltese: F'ċelluli normali, reparazzjoni ta' rikombinazzjoni omologa (HRR), li titlob ġeni BRCA1 u 2 funzjonali, hija effikaċi fir-reparazzjoni ta' dawn id-DSBs ta' DNA.
English: Number of patients at risk:
Maltese: Numru ta' pazjenti f'riskju:
English: PFS2 (31% maturity)
Maltese: PFS2 (maturità ta' 40 %)
English: Ovarian cancer Lynparza is indicated as monotherapy for the:
Maltese: Kanċer tal-ovarji Lynparza huwa indikat:
English: Other medicines and Lynparza
Maltese: Mediċini oħra u Lynparza
English: (E172), iron oxide black (E172) (150 mg tablets only).
Maltese: iron oxide iswed (E172) (150 mg pilloli biss).
English: Race (%) White Asian Other
Maltese: Razza (%) Bojod Asjatiċi Oħrajn
English: BOTTLE/LABEL
Maltese: FLIXKUN/TIKKETTA
English: How to store Lynparza 6.
Maltese: Kif taħżen Lynparza 6.
English: Olaparib showed no mutagenic potential, but was clastogenic in mammalian cells in vitro.
Maltese: Olaparib ma wera ebda potenzjal mutaġeniku, iżda kien klastoġeniku fiċ-ċelluli mammiferi in vitro.
English: Olaparib inhibits CYP3A4 in vitro and is predicted to be a mild CYP3A inhibitor in vivo.
Maltese: Olaparib jinibixxi CYP3A4 in vitro u huma previst li jkun inibitur CYP3A ħafif in vivo.
English: Lynparza capsules can be stored for up to 3 months below 30°C.
Maltese: Lynparza kapsuli jistgħu jinħażnu sa 3 xhur f'temperatura taħt 30°C.
English: Olaparib does not affect the pharmacokinetics of tamoxifen.
Maltese: Olaparib ma jaffettwax il-farmakokinetika ta' tamoxifen.
English: TFST - DCO 09 May 2016
Maltese: TFST - DCO 09 ta' Mejju 2016
English: Nausea events led to discontinuation in 2.3% of olaparib-treated patients (CTCAE Grade 2) and 0.8% of placebo-treated patients (CTCAE Grade 1); 0.8% and 0.4% of olaparib-treated patients discontinued treatment due to low grade (CTCAE Grade 2) vomiting and dyspepsia, respectively.
Maltese: Avvenimenti ta' nawsja wasslu għal twaqqif fi 2.3% tal-pazjenti kkurati b'olaparib (CTCAE Grad 2) u 0.8% tal-pazjenti kkurati bil-plaċebo (CTCAE Grad 1); 0.8% u 0.4% tal-pazjenti kkurati b'olaparibwaqqfu l-kura minħabba rimettar u dispepsja ta' grad baxx (CTCAE Grad 2), rispettivament.
English: Table 8
Maltese: Tabella 5
English: Frequency of CTCAE grade 3 and above
Maltese: Frekwenza tal-grad CTCAE 3 u aktar
English: Placebo Olaparib 400 mg capsule bd
Maltese: Plaċebo Olaparib 400 mg kapsula bd
English: No previous treatment with a PARP inhibitor, including olaparib, was permitted.
Maltese: Ma kinitx permessa trattament preċedenti b'inibitur PARP, inkluż olaparib.
English: • sore mouth (stomatitis).
Maltese: • ħalq misluħ (stomatite).
English: In first-line ovarian cancer maintenance treatment, patients experienced nausea events (77% on olaparib, 38% on placebo), vomiting (40% on olaparib, 15% on placebo), diarrhoea (34% on olaparib, 25% on placebo) and dyspepsia (17% on olaparib, 12% on placebo).
Maltese: Fil-kura ta' manteniment tal-ewwel linja għal kanċer tal-ovarji, il-pazjenti esperjenzaw avvenimenti ta' nawsja (77% fuq olaparib, 38% fuq plaċebo), rimettar (40% fuq olaparib, 15% fuq plaċebo), dijarea (34% fuq olaparib, 25% fuq plaċebo) u dispepsja (17% fuq olaparib, 12% fuq plaċebo).
English: Effect of other medicinal products on olaparib
Maltese: Effett ta' prodotti mediċinali oħra fuq olaparib
English: Olaparib 400 mg capsule bd
Maltese: Olaparib 400 mg kapsula bd
English: The potential for olaparib to induce CYP2C9, CYP2C19 and P-gp can also not be excluded.
Maltese: Il-potenzjal biex olaparib jinduċi CYP2C9, CYP2C19 u P-gp ukoll ma jistax jiġi eskluż.
English: Secondary endpoints included PFS2, OS, objective response rate (ORR) and HRQoL.
Maltese: L-end-points sekondarji inkludew PFS2, OS, rata ta' rispons oġġettiv (ORR) u HRQoL.
English: OS (64% maturity) - DCO 25 September 2017
Maltese: OS (maturità ta' 64%) - DCO 25 ta' Settembru 2017
English: Overall disease classification Metastatic
Maltese: Klassifikazzjoni tal-marda globali Metastatika
English: Median time (months) (95% CI) HR (95% CI)
Maltese: Żmien medjan (xhur) (95% CI) HR (95% CI)
English: Leukopenia Uncommon Lymphopenia
Maltese: Lewkopenja Komuni Limfopenja
English: Figure 4 Study 19: Kaplan-Meier plot of PFS in the FAS (58% maturity - investigator assessment) DCO 30 June 2010
Maltese: Figura 4 Studju 19: Plott Kaplain-Meier tal-PFS fil-FAS (maturità ta' 58% - valutazzjoni talinvestigatur) DCO 30 ta' Ġunju 2010
English: Secondary efficacy endpoints included OS, disease control rate (DCR) defined as confirmed CR/PR + SD (stable disease), HRQoL and disease related symptoms.
Maltese: End-points tal-effikaċja sekondarja kienu jinkludu OS, rata tal-kontroll tal-marda (DCR, disease control rate) definita bħala CR/PR ikkonfermat + SD (marda stabbli, stable disease), HRQoL u sintomi relatati mal-marda.
English: Maintenance treatment of platinum-sensitive relapsed (PSR) ovarian cancer SOLO2 Study
Maltese: Kura ta' manteniment ta' kanċer tal-ovarji rikadut sensittiv għall-platinu (PSR) Studju SOLO2
English: As subsequent therapy, 0.5% and 8% of patients received a PARP inhibitor in the treatment and comparator arms, respectively; 29% and 42% of patients, respectively, received subsequent platinum therapy.
Maltese: Bħala terapija sussegwenti, 0.5 % u 8 % tal-pazjenti rċivew inibitur PARP fil-fergħat tat-trattament u l-komparatur, rispettivament; 29 % u 42 % tal-pazjenti, rispettivament, irċivew terapija sussegwenti bi platinu.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX46
Maltese: Kategorija farmokoterapewtika: aġenti antineoplastiċi, aġenti antineoplastiċi oħra, kodiċi ATC:
English: For the secondary endpoint of OS, the HR for olaparib versus placebo was 0.62 (95% CI 0.42-0.93; p=0.02140; median 34.9 months versus 30.2 months) (Table 2).
Maltese: Għall-end-point sekondarju ta' OS, l-HR għal olaparib kontra plaċebo kien 0.62 (95% CI 0.42-0.93; p=0.02140; medja ta' 30.2 xhur) (Tabella 2).
English: Elimination Following a single dose of
Maltese: Eliminazzjoni Wara doża unika ta'
English: A clinical study to evaluate the impact of rifampicin, a known CYP3A inducer, has shown that co-administration with olaparib decreased olaparib mean Cmax by 71% (90% CI: 76-67%) and mean AUC by 87% (90% CI: 89-84%).
Maltese: Studju kliniku biex jevalwa l-impatt ta' rifampicin, induttur magħruf ta' CYP3A, wera li l-għoti flimkien ma' olaparib naqqas is-Cmax medju ta' olaparib b'71% (90% CI: 76-67%) u l-AUC medju b'87% (90% CI: 89-84%).
English: Pack of 448 capsules (4 bottles of 112 capsules).
Maltese: Pakkett ta' 448 kapsula (4 flixken ta' 112-il kapsula).
English: Figure 3 SOLO2: Kaplan-Meier plot of PFS in patients with gBRCA1/2m PSR ovarian cancer (63% maturity - investigator assessment)
Maltese: Figura 3 SOLO2: Plott Kaplan-Meier ta' PFS f'pazjenti b'kanċer tal-ovarji PSR gBRCA1/2m (maturità ta' 63 - valutazzjoni tal-investigatur)
English: In vitro, olaparib has been shown to be an inhibitor of BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 and MATE2K.
Maltese: In vitro, olaparib intwera li huwa inibitur ta' BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 u MATE2K.
English: There are limited clinical data available in non-Caucasian patients.
Maltese: Hemm data klinika limitata disponibbli f'pazjenti mhux Bojod.
English: A clinical study to evaluate the impact of itraconazole, a known CYP3A inhibitor, has shown that coadministration with olaparib increased mean olaparib Cmax by 42% (90% CI: 33-52%) and mean AUC by 170% (90% CI: 144-197%).
Maltese: Studju kliniku sabiex jevalwa l-impatt ta' itraconazole, inibitur CYP3A magħruf wera li l-għoti flimkien ma' olaparib żied is-Cmax medju ta' olaparib bi 42 % (90% CI: 33-52%) u AUC medju b'170 % (90% CI: 144-197%).
English: The primary endpoint was PFS assessed by blinded independent central review (BICR) using RECIST 1.1.
Maltese: L-end-point primarju kien il-PFS ivvalutata minn reviżjoni ċentrali indipendenti blinded (BICR) permezz ta' RECIST 1.1.
English: Seven patients, all stage IV, had no cytoreductive surgery.
Maltese: Seba' pazjenti, kollha ta' stadju IV, ma saritilhom l-ebda kirurġija ċitoreduttiva.
English: The secondary endpoints TFST and PFS2 demonstrated a persistent and statistically significant improvement for olaparib compared with placebo (Table 4).
Maltese: L-end-points sekondarji TFST u PFS2 urew titjib persistenti u statistikament sinifikanti għal olaparib meta mqabbel mal-plaċebo (Tabella 4).
English: The pharmacokinetics of olaparib at the 300 mg tablet dose are characterised by an apparent plasma clearance of ~7 L/h, an apparent volume of distribution of ~158 L and a terminal half-life of 15 hours.
Maltese: Il-farmakokinetika ta' olaparib bid-doża tal-pillola 300 mg hija kkaratterizata minn tneħħija tal-plażma apparenti ta' ~7 L/h, volum ta' distribuzzjoni apparenti ta' ~158 L u nofs ħajja terminali ta' 15il siegħa.
English: • bosentan - used to treat pulmonary artery hypertension
Maltese: • bosentan użat biex jikkura ipertensjoni arterjali pulmonari
English: In vitro, olaparib produced little/no inhibition of UGT1A4, UGT1A9, UGT2B7, or CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 or 2E1 and is not expected to be a clinically significant time dependent inhibitor of any of these CYP enzymes.
Maltese: In vitro, olaparib ipproduċa ftit/xejn inibizzjoni ta' UGT1A4, UGT1A9, UGT2B7, jew CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 jew 2E1 u mhuwiex mistenni li jkun inibitur dipendenti fuq iż-żmien klinikament sinifikanti ta' xi waħda minn dawn l-enzimi ta' CYP. Olaparib inibixxa UGT1A1 in vitro, madankollu, simulazzjonijiet PBPK jissuġġerixxu li dan mhuwiex ta' importanza klinika.
English: In vitro, olaparib inhibits the efflux transporter P-gp (IC50 = 76µM), therefore it cannot be excluded that olaparib may cause clinically relevant drug interactions with substrates of P-gp (e.g. simvastatin, pravastatin, dabigatran, digoxin and colchicine).
Maltese: Olaparib in vitro jinibixxi trasportatur tal-effluss P-gp (IC50=76µM), għaldaqstant ma jistax jiġi eskluż li olaparib jista' jikkawża interazzjonijiet tal-mediċina klinikament relevanti ma' sottostrati ta' P-gp (eż. simvastatin, pravastatin, dabigatran, digoxin u colchicine).
English: CYP3A4/5 are the isozymes predominantly responsible for the metabolic clearance of olaparib.
Maltese: CYP3A4/5 huma l-isoenzimi prinċipalment responsabbli għall-eliminazzjoni metabolika ta' olaparib.
English: • you have certain side effects while you are taking Lynparza (see section 4).
Maltese: • inti jkollok ċerti effetti sekondarji waqt li tkun qed tieħu Lynparza (ara sezzjoni 4).
English: Detection of BRCA1/2 mutations
Maltese: Detezzjoni ta' mutazzjonijiet BRCA1/2
English: Lynparza 100 mg tablets olaparib
Maltese: Lynparza 100 mg pilloli olaparib
English: In vitro, CYP3A4/5 were shown to be the enzymes primarily responsible for the metabolism of olaparib (see section 4.5).
Maltese: In vitro, CYP3A4/5 intwerew li huma l-enzimi primarjament responsabbli għall-metaboliżmu ta' olaparib (ara sezzjoni 4.5).
English: The most common histological type was serous (96%), endometrioid histology was reported in 2% of the patients.
Maltese: L-aktar tip istoloġiku komuni kien seruż (96 %), l-istoloġija endometrijojde ġiet irrappurtata fi 2 % tal-pazjenti.
English: Film-coated tablets Multipack: 112 (2 packs of 56) film-coated tablets
Maltese: Pilloli miksijin b'rita Pakkett multiplu: 112 (2 pakketti ta' 56)-il pillola miksija b'rita
English: Number of events: Total number of patients (%)
Maltese: Avvenimenti/pazjenti (%)
English: Therefore, known strong inducers of this isozyme (e.g. phenytoin, rifampicin, rifapentine, carbamazepine, nevirapine, phenobarbital and St John's Wort) are not recommended with Lynparza, as it is possible that the efficacy of Lynparza could be substantially reduced.
Maltese: Għaldaqstant, indutturi qawwija magħrufin ta' din l-isożima (eż. phenytoin, rifampicin, rifapentine, carbamazepine, nevirapine, phenobarbital u St John's Wort) mhumiex rakkomandati ma' Lynparza, peress li hu possibbli li l-effikaċja ta' Lynparza tista' titnaqqas b'mod sostanzjali.
English: They received an average of 3 previous chemotherapy regimens (range 2-11) and 2.6 previous platinum-containing chemotherapies (range 2-8).
Maltese: Huma rċevew medja ta' 3 reġimi preċedenti ta' kimoterapija (medda 2-11) u 2.6 kimoterapiji preċedenti li jinkludu l-platinum (medda ta' 2-8).
English: Pneumonitis, including events with a fatal outcome, has been reported in <1.0% of patients treated with Lynparza in clinical studies.
Maltese: Il-pulmonite, inkluż avvenimenti b'riżultat fatali, ġiet irrappurtata f'<1.0 % pazjenti kkurati b'Lynparza fl-istudji kliniċi.
English: Important differences in posology between Lynparza tablets and capsules Lynparza tablets (100 mg and 150 mg) should not be substituted for Lynparza capsules (50 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
Maltese: Differenzi importanti fil-pożoloġija bejn Lynparza pilloli u kapsuli Lynparza pilloli (100 mg u 150 mg) m'għandhomx jiġu sostituti b'Lynparza kapsuli (50 mg) fuq bażi ta' milligramma għal milligramma minħabba differenzi fid-dożaġġ u l-bijodisponibblità ta' kull formulazzjoni.
English: Adverse reactions that most commonly led to permanent discontinuation were anaemia (1.3%), nausea (0.8%) and thrombocytopenia (0.5%).
Maltese: Ir-reazzjonijiet avversi li bl-aktar mod komuni wasslu għal twaqqif permanenti kienu anemija (1.3%), nawsja (0.8%) u tromboċitopenija (0.5%).
English: Nausea events led to dose interruption and dose reductions in 14% and 4%, respectively, of olaparib-treated patients.
Maltese: Avvenimenti ta' nawsja wasslu għal interruzzjoni fid-doża f'14% u 4%, rispettivament, tal-pazjenti kkurati b'olaparib.
English: The most common histological type was serous (> 90%), endometrioid histology was reported in 6% of the patients.
Maltese: L-aktar tip istoloġiku komuni kien seruż (>90 %), l-istoloġija endometrijojde ġiet irrappurtata f'6 % tal-pazjenti.
English: Lynparza 150 mg tablets olaparib
Maltese: Lynparza 150 mg pilloli olaparib
English: By central germline testing, deleterious or suspected deleterious mutations were identified in 95.3% (365/383) and 4.7% (18/383) of patients, respectively.
Maltese: 3 % (365/383) u 4.7% (18/383) tal-pazjenti, rispettivamenti.
English: Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from available data).
Maltese: Il-frekwenzi ta' okkorrenza ta' reazzjonijiet avversi huma ddefiniti bħala: komuni ħafna (≥1/10); komuni (1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: (See previous paragraph: “Women of childbearing potential/contraception in females” for further information about birth control and pregnancy testing.)
Maltese: (Ara l-paragrafu ta' qabel “Nisa li jistgħu joħorġu tqal/kontraċezzjoni tannisa” għal iktar informazzjoni dwar il-kontroll tat-twelid u l-ittestjar tat-tqala.)
English: Olaparib 400 mg bd Placebo
Maltese: Olaparib 400 mg bd Plaċebo
English: In vitro, olaparib inhibits the efflux transporter P-gp (IC50 = 76 µM), therefore it cannot be excluded that olaparib may cause clinically relevant drug interactions with substrates of P-gp (e.g. simvastatin, pravastatin, dabigatran, digoxin and colchicine).
Maltese: In vitro, olaparib jinibixxi t-trasportatur tal-effluss P-gp (IC50=76 µM), għaldaqstant, ma jistax jiġi eskluż li olaparib jista' jikkawża interazzjonijiet tal-mediċina klinikament relevanti ma' substrati ta' P-gp (eż. simvastatin, pravastatin, dabigatran, digoxin u kolkiċina).
English: PFS (51% maturity)
Maltese: PFS (51% maturità) Numru ta' avvenimenti:
English: PFS (DCO 30 June
Maltese: PFS (DCO 30 ta' Ġunju 2010)
English: The primary endpoint was PFS (progression-free survival) based on investigator assessment using RECIST 1.0.
Maltese: Il-punt finali primarju kien PFS (sopravivenza mingħajr progressjoni) abbażi ta' valutazzjoni tal-investigatur permezz ta' RECIST 1.0.
English: -----olaparib 400 mg bd twice daily, ____ placebo, x-axis=time from randomisation in months, yaxis=PFS (progression-free survival), n-olaparib= number of patients at risk-olaparib, n-placebo=number of patients at risk-placebo
Maltese: ----- olaparib 400 mg bd darbtejn kuljum, ____ plaċebo, assi x =żmien mir-randomizzazzjoni f'xhur, assi y=PFS (sopravivenza mingħajr progress), n-olaparib= numri ta' pazjenti f'riskju-olaparib, nplaċebo=numru ta' pazjenti f'riskju-plaċebo
English: The Grade ≥ 3 adverse reactions occurring in > 2% of patients were anaemia (16%), neutropenia (6%), fatigue/asthenia (6%), leukopenia (3%), thrombocytopenia (2%) and vomiting (2%).
Maltese: Ir-reazzjonijiet avversi ta' Grad ≥ 3 li seħħew f'> 2% tal-pazjenti kienu anemija (16%), newtropenija (6%), għeja/astenija (6%), lewkopenija (3%), tromboċitopenija (2%) u rimettar (2%).
English: The incidence of dose interruptions, reductions and discontinuations due to an adverse event was 34.6%, 25.7% and 5.9%, respectively.
Maltese: Linċidenza tal-interruzzjonijiet, tat-tnaqqis u tat-twaqqif tad-doża minħabba avveniment avvers kienet 34.6%, 25.
English: TFST (49% maturity)
Maltese: TFST (49% maturità) Numru ta' avvenimenti:
English: Olaparib 300 mg tablet bd Placebo
Maltese: Olaparib 300 mg pillola bd Plaċebo
English: There are limited data in patients with somatic BRCA mutated tumours; 10 patients in the olaparib arm and 10 patients in the placebo arm were defined as having somatic BRCA1/2 mutation.
Maltese: Hemm dejta limitata f'pazjenti b'tumuri b'mutazzjoni ta' BRCA somatika; 10 pazjenti fil-fergħa ta' olaparib u 10 pazjenti fil-fergħa tal-plaċebo ġew definiti bħala li kellhom mutazzjoni ta' BRCA1/2 somatika.
English: See section 2 “Information on other ingredients in this medicine”.
Maltese: Ara sezzjoni 2 “Informazzjoni dwar ingredjenti oħra f'din il-mediċina”.
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of olaparib in paediatric patients.
Maltese: Ma twettaq ebda studju biex tiġi investigata l-farmakokinetika ta' olaparib f'pazjenti pedjatriċi.
English: In vitro, human plasma protein binding of olaparib was dose-dependent; the fraction bound was approximately 91% at 1 µg/mL, reducing to 82% at 10 µg/mL and to 70% at 40 µg/mL.
Maltese: In vitro, l-irbit tal-proteina tal-plażma fil-bniedem ta' olaparib kien dipendenti fuq id-doża; il-frazzjoni marbuta kienet madwar 91 % b'1 µg/mL, li naqset għal 82 % b'10 µg/mL u għal 70 % b'40 µg/mL.
English: Large rearrangements in the BRCA1/2 genes were detected in 7.4% (10/136) of the randomised patients.
Maltese: Ġew identifikati arranġamenti mill-ġdid kbar f'7.4 % (10/136) tal-pazjenti randomizzati.
English: Previous taxane treatment in (neo)adjuvant setting metastatic setting
Maltese: Trattament preċedenti b'taxane fl-ambjent (neo)aġġuvanti ambjent metastatiku
English: Combination with anastrozole, letrozole and tamoxifen A clinical study has been performed to assess the combination of olaparib with anastrozole, letrozole or tamoxifen.
Maltese: Kombinazzjoni ma' anastrozole, letrozole u tamoxifen Sar studju kliniku biex jivvaluta l-kombinazzjoni ta' olaparib ma' anastrozole, letrozole u tamoxifen.
English: Patients with CR defined by the investigator had HR 0.34 (95% CI 0.24-0.47); median PFS not reached on olaparib vs 15.3 months on placebo.
Maltese: Il-pazjenti b'CR definit mill-investigatur kellhom HR 0.34 (95% CI 0.24-0.47); PFS medjana li ma ntlaħqitx fuq olaparib kontra 15.3 xhur fuq plaċebo.
English: OS - DCO 09 May 2016
Maltese: OS - DCO 09 ta' Mejju 2016
English: • you have problems with your kidneys.
Maltese: • inti għandek problemi fil-kliewi tiegħek.
English: Figure 5 Study 19: Kaplan Meier plot of OS in the FAS (79% maturity) DCO 09 May 2016
Maltese: Studju 19: Plott Kaplain-Meier tal-PFS fil-FAS (maturità ta' 79% - valutazzjoni talinvestigatur) DCO 09 ta' Mejju 2016
English: Median PFS (months)
Maltese: PFS medju (xhur)
English: At 2 years, 43% olaparib-treated patients remained progression free compared with only 15% placebo-treated patients.
Maltese: Wara sentejn, 43 % talpazjenti kkurati b'olaparib baqgħu mingħajr progressjoni meta mqabbel ma' 15 % biss tal-pazjenti kkurati bil-plaċebo.
English: C-olaparib, ~86% of the dosed radioactivity was recovered within a 7-day collection period, ~44% via the urine and ~42% via the faeces.
Maltese: C-olaparib, ~86% tar-radjuattività ddożata ġiet irkuprata fi żmien perjodu ta' ġbir ta' 7 ijiem, ~44% mill-awrina u ~42% mill-ippurgar.
English: Lynparza is supplied in packs containing 56 film-coated tablets (7 blisters of 8 tablets each), or multipacks containing 112 (2 packs of 56) film-coated tablets.
Maltese: Lynparza jiġi fornut f'pakketti li fihom 56 pillola miksija b'rita (7 folji ta' 8 pilloli kull waħda), jew pakketti multipli li fihom112 (2 pakketti ta' 56)-il pillola miksija b'rita.
English: At 24 and 36 months, respectively, 68% and 45% patients remained in CR in the olaparib arm, and 34% and 22% of patients in the placebo arm.
Maltese: Wara 24 u 36 xahar, rispettivament, 68 % u 45 % tal-pazjenti baqgħu f'CR fil-fergħa ta' olaparib, u 34 % u 22 % talpazjenti fil-fergħa tal-plaċebo.