FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended Lynparza dose reduction is to 100 mg taken twice daily (equivalent to a total daily dose of 200 mg) with a strong CYP3A inhibitor or 150 mg taken twice daily (equivalent to a total daily dose of 300 mg) with a moderate CYP3A inhibitor (see sections 4.2 and 4.4).
Maltese: It-tnaqqis rakkomandat fid-doża ta' Lynparza huwa għal 100 mg li jittieħed darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 200 mg) ma' inibitur qawwi ta' CYP3A jew 150 mg li jittieħed darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 300 mg) ma' inibitur moderat ta' CYP3A (ara sezzjonijiet 4.2 u 4.4).
English: Confirmed ORR - DCO 09 December 2016
Maltese: ORR ikkonfermata - DCO 09 ta' Diċembru 2016
English: The most frequently observed adverse reactions across clinical trials in patients receiving Lynparza monotherapy (≥ 10%) were nausea, vomiting, diarrhoea, dyspepsia, fatigue, headache, dysgeusia, decreased appetite, dizziness, upper abdominal pain, cough, dyspnoea, anaemia, neutropenia, thrombocytopenia and leukopenia.
Maltese: Ir-reazzjonijiet avversi osservati l-aktar frekwentement fil-provi kliniċi kollha f'pazjenti li jirċievu monoterapija b'Lynparza (≥ 10%) kienu nawsja, rimettar, dijarea, dispepsja, għeja (inkluż astenija), uġigħ ta' ras, disgewsja, tnaqqis fl-aptit, sturdament, uġigħ fil-parti ta' fuq tal-addome, sogħla, qtugħ ta' nifs, anemija, newtropenija, tromboċitopenija u lewkopenija.
English: 27.9 (22.6-NR)
Maltese: Żmien medjan (xhur) (95% CI) 27.9 (22.6-NR)
English: It is also not recommended to consume grapefruit juice while on Lynparza therapy as it is a CYP3A inhibitor.
Maltese: Mhuwiex rakkomandat ukoll li tikkonsoma l-meraq tal-grejpfrut waqt it-terapija Lynparza peress li huwa inibitur CYP3A.
English: Ovarian cancer was the primary tumour in >80% of the patients.
Maltese: Il-kanċer tal-ovarji kien it-tumur primarju f'>80 % tal-pazjenti.
English: Patients with germline or somatic BRCA1/2 mutations were identified prospectively either from germline testing in blood via a local test (n=208) or central test (n=181) or from testing a tumour sample using a local test (n=2).
Maltese: Il-pazjenti b'mutazzjonijiet BRCA1/2 tal-linja ġerminali jew somatiċi ġew identifikati b'mod prospettiv jew mill-ittestjar tal-linja ġerminali fid-demm permezz ta' test lokali (n=208) jew minn test ċentrali (n-181) jew mill-ittestjar ta' kampjun tat-tumur permezz ta' test lokali (n=2).
English: For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 200 mg (two 100 mg tablets) twice daily (equivalent to a total daily dose of 400 mg) (see section 5.2).
Maltese: Għal pazjenti b'indeboliment tal-kliewi moderat (tneħħija tal-kreatinina 31 sa 50 ml/min) id-doża rakkomandata ta' Lynparza hija ta' 200 mg (żewġ pilloli ta' 100 mg) darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 400 mg) (ara sezzjoni 5.2).
English: In the placebo-treated group, 8.1% of patients remained on treatment for ≥2 years and 1.6% for ≥5 years.
Maltese: Fil-grupp ikkurat bilplaċebo, 8.1 % tal-pazjenti baqgħu fuq il-kura għal ≥sentejn u 1.6 % għal 5 snin.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide black (E172) (150 mg tablets only)
Maltese: Ossidu tal-ħadid isfar (E172) Ossidu tal-ħadid iswed (E172) (150 mg pilloli biss)
English: • statins, for example simvastatin, pravastatin, rosuvastatin - used to lower blood cholesterol levels
Maltese: • statins, pereżempju simvastatinpravastatin, rosuvastatin - użati sabiex ibaxxu l-livelli tal kolesterol fid-demm
English: Lynparza is available as 100 mg and 150 mg tablets.
Maltese: Lynparza jiġi bħala pilloli ta' 100 mg u 150 mg.
English: Vomiting, Diarrhoea, Nausea Uncommon
Maltese: Komuni Remettar, Dijarea, Nawsja
English: The time from randomisation to start of second subsequent therapy or death (TSST) was 6.1 months longer for olaparib-treated patients (HR 0.43; 95% CI 0.29-0.64; p=0.00003; median 21.4 months versus 15.3 months).
Maltese: Iż-żmien mirrandomizzazzjoni sal-bidu tal-ewwel terapija sussegwenti jew mewt (TFST) kien 6.1 xhur itwal għal pazjenti kkurati b'olaparib (HR 0.43; 95% CI 0.29-0.64; p=0.00003; medja ta' 21.4 xhur meta mqabbel ma' 15.3 xhur.
English: Lynparza 150 mg tablets are green to green/grey, oval, bi-convex, film-coated tablets, marked with “OP150” on one side and plain on the other.
Maltese: Lynparza 150 mg pilloli huma pilloli miksijin b'rita ħodor għal ħodor/griżi, ovali, bikonvessi, immarkati b'“OP150” fuq naħa waħda u b'xejn fuq in-naħa l-oħra.
English: • you are taking certain medicines that may affect Lynparza (see section 2).
Maltese: • inti qed tieħu ċerti mediċini li jistgħu jaffettwaw Lynparza (ara sezzjoni 2).
English: In vitro, olaparib is a substrate of the efflux transporter P-gp, however this is unlikely to be of clinical significance (see section 4.5).
Maltese: In vitro, olaparib huwa substrat tat-trasportatur tal-efflus P-gp, madankollu, dan aktarx mhuwiex ta' sinifikanza klinika (ara sezzjoni 4.5).
English: Figure 2 Study 19: Kaplan-Meier plot of OS in BRCA-mutated patients (73% maturity)
Maltese: 2 Studju 19: Plott ta' Kaplan-Meier ta' OS f'pazjenti b'mutazzjoni ta' BRCA (73% maturità)
English: • methotrexate - used to treat cancer, rheumatoid arthritis and psoriasis.
Maltese: • methotrexate użat biex jikkura l-kanċer, l-artrite rewmatojde u l-psorjażi.
English: No significant interaction was observed with anastrozole or letrozole, whereas tamoxifen decreased exposure to olaparib by 27%.
Maltese: Ma ġiet osservata l-ebda interazzjoni sinifikanti b'anastrozole jew letrozole, waqt li tamoxifen naqqas l-esponiment għal olaparib b'27 %.
English: Elderly
Maltese: Kimoterapija
English: Lynparza is a white, opaque, hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink.
Maltese: Lynparza hija kapsula bajda, opaka u iebsa ta' daqs 0, immarkata b'”OLAPARIB 50 mg” u l-logo AstraZeneca b'linka sewda.
English: Based on Kaplan-Meier estimates, the proportion of patients that were progression free at 24 and 36 months were 74% and 60% for olaparib versus 35% and 27% for placebo; the median follow-up time was 41 months for both the olaparib and placebo arms.
Maltese: Abbażi ta' stimi ta' Kaplan -Meier, il-proporzjon ta' pazjenti li kienu mingħajr progressjoni wara 24 u 36 xahar kienu 74 % u 60 % għal olaparib kontra 35 % u 27 % għall-plaċebo; iż-żmien ta' segwitu medjan kien 41 xahar kemm għall-fergħa ta' olaparib kif ukoll tal-plaċebo.
English: • feeling dizzy
Maltese: • tħossok storduta
English: Male patients:
Maltese: Pazjenti rġiel:
English: For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 300 mg twice daily (equivalent to a total daily dose of 600 mg) (see section 5.2).
Maltese: Għal pazjenti b'indeboliment tal-kliewi moderat (tneħħija tal-kreatinina ta' 31 sa 50 ml/min), id-doża rakkomandata ta' Lynparza hija 300 mg darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 600 mg) (ara sezzjoni 5.2).
English: There are no data in patients with severe renal impairment or end-stage renal disease (creatinine clearance <30 ml/min).
Maltese: Mhemmx data f'pazjenti b'indeboliment sever jew mard tal-kliewi tal-aħħar stadju (tneħħija ta' kreatinina <30 ml/min).
English: The analysis was performed using a Cox proportional hazards model including response to previous platinum chemotherapy (CR or PR) as a covariate.
Maltese: L-analiżi saret bl-użu ta' mudell ta' periklu proporzjonali Cox inkluż irrispons għal kimoterapija preċedenti bil-platinu (CR jew PR) bħala kovarjat.
English: For germline breast cancer susceptibility genes (gBRCA1/2) mutated human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, patients must have confirmation of a deleterious or suspected deleterious gBRCA1/2 mutation before Lynparza treatment is initiated.
Maltese: Kanċer tas-sider metastatiku negattiv għall-HER2 b'mutazzjoni gBRCA1/2: Huwa rakkomandat li l-kura titkompla sal-progressjoni tal-marda sottostanti jew tossiċità mhux aċċettabbli.
English: Within the BRCA-mutated population the disease control rate at 24 weeks was 57% and 24% for patients in the olaparib and placebo groups, respectively.
Maltese: Fil-popolazzjoni b'mutazzjoni ta' BRCA, ir-rata ta' kontroll tal-marda fl-24 ġimgħa kienet 57% u 24% għal pazjenti filgruppi ta' olaparib u plaċebo, rispettivament.
English: Co-administration with food slowed the rate (tmax delayed by 2.5 hours and Cmax reduced by approximately 21%) but did not significantly affect the extent of absorption of olaparib (AUC increased 8%).
Maltese: L-għoti flimkien mal-ikel dewwem ir-rata (tmax ittardjat b'2.5 sigħat u Cmax imnaqqsa b'madwar 21%) iżda ma affettwax b'mod sinifikanti l-limitu tal-assorbiment ta' olaparib (AUC miżjuda b'8%).
English: Maintenance treatment of platinum sensitive relapsed ovarian cancer:
Maltese: Kura ta' manteniment għal kanċer tal-ovarji rikadut sensittiv għall-platinu:
English: The analysis was performed using a Cox proportional hazards model with factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Maltese: L-analiżi saret bl-użu ta' mudell ta' perikli proporzjonati b'fatturi għall-kura, id-dixxendent etniku, is-sensittività għall-platinu u r-rispons għat-terapija finali bil platinu.
English: If preferred, you can keep Lynparza capsules out of the refrigerator (below 30°C) for up to 3 months.
Maltese: Jekk tippreferi, tista' żżomm Lynparza kapsuli barra mill-friġġ (f'temperatura taħt 30°C) sa 3 xhur.
English: Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Maltese: Lynparza huwa indikat bħala monoterapija għall-kura ta' manteniment ta' pazjenti adulti b'kanċer talovarji epiteljali b'gradi għoljin ta' seru b'mutazzjoni ta' BRCA rkaduta (linja ġerminali u/jew somatika), sensittivi għall-platinum, tat-tubu fallopjan jew tal-peritonew primarju li jkunu qed iwieġbu (rispons sħiħ jew rispons parzjali) għal kimoterapija bbażata fuq il-platinum.
English: Retreatment with olaparib was not permitted following progression on olaparib.
Maltese: Il-kura mill-ġdid b'olaparib ma kinitx permessa wara progressjoni fuq olaparib.
English: The investigator assessment of PFS was supported with a blinded independent central radiological review of PFS (HR 0.25; 95% CI 0.18-0.35; p<0.0001; median 30.2 months for olaparib and 5.5 months placebo).
Maltese: Il-valutazzjoni tal-investigatur talPFS ġiet appoġġjata minn reviżjoni radjuloġika ċentrali indipendenti blinded tal-PFS (HR 0.25; 95% CI 0.18-0.35; p<0.
English: Lynparza co-administration with strong or moderate CYP3A inhibitors is not recommended (see section 4.5).
Maltese: L-għoti flimkien ta' Lynparza ma' inibituri CYP3A mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Alu/Alu non-perforated blister containing 8 film-coated tablets.
Maltese: Folja mhux perforata tal-Alu/Alu li fiha 8 pilloli miksijin b'rita.
English: Since it cannot be excluded that olaparib may reduce exposure to substrates of CYP2C9 through enzyme induction, the efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib.
Maltese: Peress li ma jistax jiġi eskluż li olaparib jista' jnaqqas l-esponiment għal substrati ta' CYP2C9 permezz ta' induzzjoni tal-enzima, l-effikaċja ta' xi kontraċettivi ormonali tista' titnaqqas jekk jingħataw flimkien ma' olaparib.
English: In patients with mild renal impairment (creatinine clearance 51 to 80 ml/min), AUC increased by 24% and Cmax by 15% compared with patients with normal renal function.
Maltese: F'pazjenti b'indeboliment tal-kliewi ħafif (tneħħija tal-kreatinina 51 sa 80 ml/min), l-AUC żdiedet b'24 % u s-Cmax b'15 % meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: Although patient numbers were limited, 13.2% (n=18/136) of the patients in the olaparib-treated group remained on treatment for ≥5 years as compared with 0.8% (n=1/128) in the placebo group.
Maltese: Għalkemm in-numri tal-pazjenti kienu limitati, 13.2 % (n=18/136) tal-pazjenti fil-grupp ikkurat b'olaparib baqgħu fuq il-kura għal ≥5 snin kif imqabbel ma' 0.8 % (n=1/128) fil-grupp tal-plaċebo.
English: Number of patients at risk Olaparib 300 mg twice daily tablet
Maltese: Numru ta' pazjenti f'riskju Olaparib 300 mg darbtejn kuljum pillola
English: The safety and efficacy of olaparib as a maintenance therapy in the treatment of platinum-sensitive relapsed (PSR) high grade serous ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a Phase II randomised, double-blind, placebo-controlled trial (study 19).
Maltese: Is-sigurtà u l-effikaċja ta' olaparib bħala terapija ta' manteniment ta' pazjenti b'kanċer tal-ovarji bi gradi għoljin ta' seru inkluż tat-tubu fallopjan jew peritonew primarju, li rkadew, sensittivi għal platinum (PSR), wara kura b'żewġ korsijiet jew aktar ta' platinum, ġew studjati fi prova kkontrollata ta' plaċebo, double blind, randomizzat tal-Fażi II (studju 19).
English: Therefore, olaparib upon co-administration may reduce the exposure to substrates of these metabolic enzymes and transport protein.
Maltese: Għaldaqstant, olaparib wara li jingħata flimkien jista' jnaqqas l-esponiment għal sottostrati ta' dawn l-enzimi metaboliċi u jittrasporta l-proteina.
English: Figure 2 SOLO1: Kaplan-Meier plot of OS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (21% maturity)
Maltese: 2 SOLO1: Plott ta' Kaplan-Meier ta' OS f'pazjenti li għadhom kif jiġu dijanjostikati b'kanċer tal-ovarji avvanzat BRCA1/2m (21% maturita)
English: Lynparza can be administered to patients with mild or moderate hepatic impairment (Child-Pugh classification A or B) with no dose adjustment (see section 5.2).
Maltese: Lynparza jista' jingħata lil pazjenti b'indeboliment tal-fwied ħafif jew moderat (Klassifikazzjoni A jew B ta' Child-Pugh) mingħajr l-ebda aġġustament fid-doża (ara sezzjoni 5.2).
English: Retrospective testing of patients with available tumour samples was performed using central testing and generated successful results in 341 patients, of which 95% had an eligible mutation (known [n=47] or likely pathogenic [n=277]) and 2 gBRCAwt patients were confirmed to have sBRCAm only.
Maltese: L-ittestjar retrospettiv tal-pazjenti b'kampjuni tat-tumur disponibbli sar permezz tal-ittestjar ċentrali u ġġenera riżultati ta' suċċess fi 341 pazjent, li minnhom 95 % kellhom mutazzjoni eleġibbli (magħrufa [n=47] jew aktarx patoġenika [n=277]) u 2 pazjenti b'gBRCAwt ġew ikkonfermati li kellhom sBRCAm biss.
English: A clinical study to evaluate the impact of itraconazole, a known CYP3A inhibitor, has shown that co-administration with olaparib increased mean olaparib Cmax by 42% (90% CI: 33-52%) and mean
Maltese: Studju kliniku biex jevalwa l-impatt ta' itraconazole, inibitur magħruf ta' CYP3A, wera li l-għoti flimkien ma' olaparib żieda is-Cmax medja ta' olaparib b'42 % (90% CI:
English: Number of objective responders: Total number of patients with measurable disease (%)
Maltese: Numru totali ta' pazjenti (%)
English: First-line maintenance treatment of BRCA-mutated advanced ovarian cancer:
Maltese: Kura ta' manteniment tal-ewwel linja għal kanċer tal-ovarji avvanzat b'mutazzjoni BRCA:
English: The duration of therapy with olaparib in patients who developed MDS/AML varied from <6 months to >2 years; data with longer durations of exposure are limited.
Maltese: It-tul tat-terapija b'olaparib f'pazjenti li żviluppaw MDS/AML varjat minn <6 xhur sa >sentejn; data b'tul ta' żmien tal-espożizzjoni itwal hija limitata.
English: The safety and efficacy of olaparib as maintenance therapy were studied in patients with newly diagnosed advanced (FIGO Stage III-IV) high-grade serous or endometrioid BRCA1/2 mutated (BRCA1/2m) ovarian cancer following completion of first-line platinum-based chemotherapy in a Phase III randomised, double-blind, placebo-controlled, multicentre trial.
Maltese: Is-sigurtà u l-effikaċja ta' olaparib bħala terapija ta' manteniment ġew studjati f'pazjenti b'kanċer talovarji avvanzat (FIGO Stadju III-IV) ta' grad għoli seruż jew tal-endometrijojde b'mutazzjoni BRCA1/2 (BRCA1/2m) li għadu kif jiġi dijanjostikat wara li temmew kimoterapija bbażata fuq ilplatinu tal-ewwel linja fi prova randomizzata, double-blind ta' Fażi
English: • allergic reactions (e.g. hives, difficulty breathing or swallowing, dizziness which are signs and symptoms of hypersensitivity reactions).
Maltese: • reazzjonijiet allerġiċi (eż. ħorriqija, diffikultà biex wieħed jieħu nifs jew biex jibla', sturdament li huma sinjali u sintomi ta' reazzjonijiet ta' sensittività eċċessiva).
English: • indigestion or heartburn (dyspepsia)
Maltese: • bidliet fit-togħma tal-ikel (disgewsja)
English: In the HR+ patient subgroup the confirmed ORR was 57% (46/81) in the olaparib arm and 33% (11/33) in the comparator arm. bd Twice daily; CI Confidence interval; DOR Duration of response; DCO Data cut off; HR Hazard ratio; HR+ Hormone receptor positive, ORR Objective response rate; OS overall survival; PFS progression-free survival; PFS2 Time to second progression or death, TNBC triple negative breast cancer.
Maltese: Fis-sottogrupp tal-pazjent HR+ l-ORR ikkonfermata kienet 57 % (46/81) fil-fergħa ta' olaparib u 33 % (11/33) fil-fergħa tal-komparatur. bd Darbtejn kuljum; CI
English: The analysis was performed using a Cox proportional hazard model including response to previous platinum chemotherapy (CR or PR), and time to disease progression (>6-12 months and >12 months) in the penultimate platinum-based chemotherapy as covariates.
Maltese: L-analiżi saret bl-użu ta' mudell ta' periklu proporzjonali ta' Cox li jinkludi r-rispons għal kimoterapija preċedenti bil-platinu (CR jew PR), u ż-żmien għall progressjoni tal-marda (>6-12-il xahar u >12-il xahar) fil-kimoterapija ta' qabel tal-aħħar ibbażata fuq il-platinu bħala kovarjati.
English: All patients had potential contributing factors for the development of MDS/AML, having received previous chemotherapy with platinum agents.
Maltese: Il-pazjenti kollha kellhom fatturi ta' kontribut potenzjali għall-iżvilupp ta' MDS/AML, wara li rċivew kimoterapija preċedenti b'aġenti tal-platinu.
English: This clastogenicity is consistent with the known pharmacology of olaparib and indicates potential for genotoxicity in man.
Maltese: Din il-klastoġeniċità hija konsistenti mal-farmakoloġija magħrufa ta' olaparib u tindika potenzjal għall-ġenotossiċità filbniedem.
English: Patients with PR at study entry either achieved CR (15% in olaparib arm and 4% in the placebo arm at 24 months, remained in CR at 36 months) or had further PR/stable disease (43% in olaparib arm and 15% in the placebo arm at 24 months; 17% in olaparib arm and 15% in placebo arm at 36 months).
Maltese: Il-pazjenti b'PR maddħul fl-istudju jew kisbu CR (15% fil-fergħa ta' olaparib u 4% fil-fergħa tal-plaċebo wara 24 xahar, baqgħu f'CR wara 36 xahar) jew kellhom PR ulterjuri/marda stabbli (43% fil-fergħa ta' olaparib u 15% fil-fergħa tal-plaċebo wara 24 xahar; 17% fil-fergħa ta' olaparib u 15% fil-fergħa tal-plaċebo wara 36 xahar).
English: Antiemetic prophylaxis is not required.
Maltese: Il-profilassi antiemetika mhijiex meħtieġa.
English: If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg (one 150 mg tablet) taken twice daily (equivalent to a total daily dose of 300 mg) (see sections 4.4 and 4.5).
Maltese: Jekk ikun jeħtieġ li jingħata flimkien inibitur moderat ta' CYP3A, it-tnaqqis fid-doża rakkomandat ta' Lynparza huwa għal 150 mg (pillola waħda ta' 150 mg) li tittieħed darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 300 mg) (ara sezzjonijiet 4.4 u 4.5).
English: In BRCA1/2-deficient in vivo models, olaparib given after platinum treatment resulted in a delay in tumour progression and an increase in overall survival compared to platinum treatment alone that correlated with the period of olaparib maintenance treatment.
Maltese: F'mudelli in vivo neqsin mill-BRCA1/2, olaparib mogħti wara kura bil-platinu rriżulta f'dewmien filprogressjoni tat-tumur u f'żieda fis-sopravivenza globali meta mqabbel mal-kura bil-platinu biss li kkorelatat mal-perjodu ta' kura ta' manteniment b'olaparib.
English: A total of 18 (13.2%) patients received treatment for ≥5 years in the olaparib group compared with 1 (0.8%) patient in the placebo group.
Maltese: Total ta' 18 (13.2%)-il pazjent irċivew kura għal ≥5 snin fil-grupp ta' olaparib meta mqabbla ma' pazjent 1 (0.8 %) fil-grupp ta' placebo.
English: Most patients were ECOG performance status 0 (78%), there are no data in patients with performance status 2 to 4.
Maltese: Ħafna mill-pazjenti kellhom status tal-prestazzjoni ECOG 0 (78 %), m'hemm l-ebda data f'pazjenti bi status tal-prestazzjoni 2 sa 4.
English: Ovarian cancer was the primary tumour in 86% of the patients.
Maltese: Il-kanċer tal-ovarji kien it-tumur primarju f'86 % tal-pazjenti.
English: Missing Number of prior lines of chemotherapy for metastatic breast cancer (%)
Maltese: Numru ta' linji preċedenti ta' kimoterapija għal kanċer tas-sider metastatiku (%)
English: If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) (see sections 4.4 and 4.5).
Maltese: Jekk ikun meħtieġ li jingħata inibitur CYP3A moderat miegħu, it-tnaqqis fid-doża ta' Lynparza rrakkomandat huwa sa 200 mg meħuda darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 400mg) (ara sezzjonijiet 4.4 u 4.5).
English: Therefore, an additional non-hormonal contraceptive method should be considered during treatment (see section 4.5).
Maltese: Għaldaqstant, għandu jiġi kkunsidrat metodu mhux ormomali addizzjonali waqt it-trattament (ara sezzjoni 4.5).
English: Efficacy results are presented in Table 2 and Figures 1 and 2.
Maltese: Ir-riżultati tal-effikaċja huma ppreżentati f'Tabella 2 u Figuri 1 u 2.
English: Thrombocytopenia a, Leukopenia
Maltese: Pilloli miksijin b'rita
English: Median, months (95% CI)
Maltese: Medjana, xhur (95% CI)
English: In rat embryofoetal development studies, and at dose levels that did not induce significant maternal toxicity, olaparib caused reduced embryofoetal survival, reduced foetal weight and foetal developmental abnormalities, including major eye malformations (e.g. anophthalmia, microphthalmia), vertebral/rib malformation and visceral and skeletal abnormalities.
Maltese: Fi studji tal-iżvilupp embrijofetali, u f'livelli ta' doża li ma induċewx tossiċità materna sinifikanti, olaparib ikkawża tnaqqis fis-sopravivenza embrijofetali, tnaqqis fil-piż tal-fetu u anomaliji fl-iżvilupp tal-fetu, inklużi malformazzjonijiet maġġuri fl-għajnejn (eż. anoftalmija, mikroftalmija), malformazzjoni vertebrali/fil-kustilji u anormalitajiet vixxerali u skeletriċi.
English: Very common Fatigue (including asthenia)
Maltese: Komuni Għeja (inkluż astenja)
English: The duration of therapy with olaparib in patients who developed MDS/AML varied from < 6 months to > 2 years.
Maltese: It-tul tat-terapija b'olaparib f'pazjenti li żviluppaw MDS/AML varjat minn < 6 xhur sa > sentejn.
English: Depending on the test used and the international classification consensus, the BRCA1/2 mutations have been classified as deleterious/suspected deleterious or pathogenic/likely pathogenic.
Maltese: Skont it-test użat u l-kunsens ta' klassifikazzjoni internazzjonali, ġew identifikati lmutazzjonijiet BRCA1/2 bħala deleterużi/suspettati deleterużi jew patoġeniċi/aktarx patoġeniċi.
English: Other laboratory findings
Maltese: Sejbiet tal-laboratorju oħra
English: Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2mutations, who have HER2 negative locally advanced or metastatic breast cancer.
Maltese: Lynparza huwa indikat bħala monoterapija għat-trattament ta' pazjenti adulti b'mutazzjonijiet BRCA1/2 germline, li għandhom kanċer tas-sider lokalment avvanzat jew metastatiku negattiv għallHER2.