FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pivotal ENGOT-OV16 study, adverse reactions (ADRs) occurring ≥ 10 % of patients receiving Zejula monotherapy were nausea, thrombocytopenia, fatigue/asthenia, anaemia, constipation, vomiting, abdominal pain, neutropenia, insomnia, headache, decreased appetite, nasopharyngitis, diarrhoea, dyspnea, hypertension, dyspepsia, back pain, dizziness, cough, urinary tract infection, arthralgia, palpitations, and dysgeusia.
Maltese: ENGOT-OV16, ir-reazzjonijiet avversi (ADRs, adverse reactions) li seħħew f'≥ 10 % tal-pazjenti li kienu qed jirċievu monoterapija b'Zejula kienu nawsja, tromboċitopenja, għeja/astenija, anemija, stitikezza, remettar, uġigħ addominali, newtropenja, insomnja, uġigħ ta' ras,
English: Niraparib is an inhibitor of MATE1 and -2 with IC50 of 0.18 µM and ≤ 0.14 µM, respectively.
Maltese: Niraparib huwa inibitur ta' MATE1 u -2 b' IC50 ta' 0.18 µM u ≤ 0.14 µM, rispettivament.
English: Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased
Maltese: Żieda fil-gamma-glutamyl transferase, żieda fl-AST, żieda fil-kreatinina tad-demm, żieda fl-ALT, żieda fil-fosfatażi alkalina fid-demm, tnaqqis filpiż
English: Do not store above 30 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30 °C.
English: Therefore, caution is recommended when niraparib is combined with active substances the metabolism of which is CYP3A4-dependent and, notably, those having a narrow therapeutic range (e.g. ciclosporin, tacrolimus, alfentanil, ergotamine, pimozide, quetiapine, and halofantrine).
Maltese: Għalhekk, hija rakkomandata l-kawtela meta niraparib jiġi kkombinat ma' sustanzi attivi li l-metaboliżmu tagħhom ikun dipendenti fuq CYP3A4 u, notevolment, dawk li jkollhom medda terapewtika dejqa (eż. ciclosporin, tacrolimus, alfentanil, ergotamine, pimozide, quetiapine, u halofantrine).
English: Niraparib as a substrate of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1)
Maltese: Niraparib bħala sottostrat ta' trasportaturi tal-assorbiment mill-fwied (OATP1B1, OATP1B3, u OCT1)
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX54.
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi oħra, Kodiċi ATC:
English: Dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis
Maltese: Mhux komuni Dijarea, stitikezza, infjammazzjoni tal-mukoża (inkluż mukożite), stomatite, ħalq xott
English: The systemic exposures (Cmax and AUC) to niraparib increased in a dose-proportional manner when the dose of niraparib increased from 30 mg to 400 mg.
Maltese: L-esponimenti sistemiċi (Cmax u AUC) għal niraparib żdiedu b'mod proporzjonali għad-doża meta ddoża ta' niraparib żdiedet minn 30 mg għal 400 mg.
English: In the NOVA study, 48 % of patients had a dose interruption in Cycle 1.
Maltese: Fl-istudju NOVA, 48 % tal-pazjenti kellhom interruzzjoni fid-doża f'Ċiklu 1.
English: Myelodysplastic syndrome/acute myeloid leukaemia
Maltese: Sindrome majelodisplastiku/lewkimja majelojde akuta
English: Dyspnea, cough, nasopharyngitis
Maltese: Komuni Nawsja, remettar, uġigħ addominali
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit (e.g. itraconazole, ritonavir, and clarithromycin) or induce CYP enzymes (e.g. rifampin, carbamazepine, and phenytoin).
Maltese: Mhu meħtieġ l-ebda aġġustament fiddoża għal Zejula meta jingħata flimkien ma' prodotti mediċinali magħrufa li jinibixxu (eż. itraconazole, ritonavir, u clarithromycin) jew jinduċu enżimi tas-CYP (eż. rifampin, carbamazepine, u phenytoin).
English: Following multiple oral doses of niraparib from 30 mg to 400 mg once daily, accumulation of niraparib was approximately 2 to 3 folds.
Maltese: Wara dożi orali multipli ta' niraparib minn 30 mg sa 400 mg darba kuljum, l-akkumulazzjoni ta' niraparib kienet madwar darbtejn sa 3 darbiet.
English: In orthotopic high-grade serous ovarian cancer patient-derived xenograft tumours (PDX) grown in mice, niraparib has been shown to reduce tumour growth in BRCA 1 and 2 mutant, BRCA wild-type but homologous recombination (HR) deficient, and in tumours that are BRCA wild-type and without detectable HR deficiency.
Maltese: Fit-tumuri xenograft derivati mill-pazjent (PDX, patient-derived xenograft) tal-kanċer ovariku seruż ta' grad għoli ortotopiku mkabbrin fil-ġrieden, niraparib wera li jnaqqas it-tkabbir tat-tumur fil-mutant BRCA 1 u 2, BRCA tat-tip selvaġġ iżda defiċjent tar-rikombinazzjoni omologa (HR, homologous recombination), u f'tumuri li huma BRCA tat-tip selvaġġ u mingħajr defiċjenza ta' HR li tiġi identifikata.
English: In a mass balance study, M1 and M10 (the subsequently formed M1 glucuronides) were the major circulating metabolites.
Maltese: Fi studju ta' bilanċ tal-massa, M1 u M10 (il-glucuronides M1 li ffurmaw sussegwentement) kienu l-metaboliti li jiċċirkulaw maġġuri.
English: Ελλάδα
Maltese: • Qtugħ ta' nifs
English: This medicine contains lactose and tartrazine - see section 2 for more information.
Maltese: Din il-mediċina fiha l-lactose u tartrazine - ara sezzjoni 2 għal aktar informazzjoni.
English: In the overall non-gBRCAmut cohort, the median number of treatment cycles was higher in the niraparib arm than in the placebo arm (8 and 5 cycles, respectively).
Maltese: Fil-koorti globali non-gBRCAmut, in-numru medjan ta' ċikli ta' kura kien ogħla fil-fergħa ta' niraparib milli fil-fergħa tal-plaċebo (8 u 5 ċikli, rispettivament).
English: The primary efficacy analysis for PFS was determined by blinded central independent assessment and was prospectively defined and assessed for the gBRCAmut cohort and the non-gBRCAmut cohort separately.
Maltese: L-analiżi tal-effikaċja primarja għall-PFS ġiet determinata minn valutazzjoni indipendenti ċentrali blinded ġiet definita u vvalutata b'mod prospettiv għall-koorti gBRCAmut u għall-koorti nongBRCAmut separatament.
English: Anxiety, depression
Maltese: Ansjetà, dipressjoni
English: If further dose reduction is needed, a second dose reduction from two hard capsules daily (200 mg) to one capsule daily (100 mg) may be implemented.
Maltese: Jekk ikun hemm bżonn ta' aktar tnaqqis fid-doża, jista' jiġi implimentat tnaqqis fid-doża sekondarju minn żewġ kapsuli ibsin kuljum (200 mg) għal kapsula waħda kuljum (100 mg).
English: placebo (N = 65)
Maltese: (N = 65)
English: The median duration of neutropenia of any grade was 26 days, and 13 days for Grade 3/4 events.
Maltese: Id-durata medjana ta' newtropenja ta' kwalunkwe grad kienet ta' 26 jum u ta' 13-il jum għal avvenimenti ta' Grad 3/4.
English: • Risk management plan (RMP)
Maltese: • Pjan tal--ġestjoni tar-riskju (RMP)
English: The most common serious adverse reactions > 1 % (treatment-emergent frequencies) were thrombocytopenia and anaemia.
Maltese: Ir-reazzjonijiet avversi serji l-aktar komuni > 1 % (frekwenzi li ħarġu mill-kura) kienu tromboċitopenja u anemija.
English: Discontinuation due to anaemia occurred in 1 % of patients.
Maltese: Kien hemm twaqqif minħabba anemija f'1 % tal-pazjenti.
English: B: Placebo
Maltese: Plaċebo
English: The safety and efficacy of niraparib as maintenance therapy was studied in a Phase 3 randomised, double-blind, placebo-controlled international trial (ENGOT-OV16 / NOVA) in patients with relapsed predominantly high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by complete response (CR) or partial response (PR) for more than six months to their penultimate (next to last) platinum-based therapy.
Maltese: randomizzata, double blind, ikkontrollata bil-plaċebo, internazzjonali (ENGOT-OV16 / NOVA) f'pazjenti b'kanċer ovariku epiteljali seruż, tat-tubu fallopjan, jew peritoneali primarju rikaduti predominanti ta' grad għoli li kienu sensittivi għall-platinu, definiti minn rispons sħiħ (CR, complete response) jew rispons parzjali (PR, partial response) għal aktar minn sitt xhur għat- terapija ta' qabel tal-aħħar tagħhom ibbażata fuq il-platinu.
English: Approximately 76 % of patients with lower baseline platelets (< 180 × 109/L) who received Zejula experienced thrombocytopenia of any grade, and 45 % of the patients experienced Grade 3/4 thrombocytopenia.
Maltese: Madwar 76 % tal-pazjenti bi plejtlits fil-linja bażi aktar baxxi (< 180 × 109/L) li rċivew Zejula esperjenzaw tromboċitopenja ta' kwalunkwe grad, u 45 % tal-pazjenti esperjenzaw tromboċitopenja ta' Grad 3/4.
English: Niraparib as a substrate of CYPs (CYP1A2 and CYP3A4) Niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs) in vivo.
Maltese: Niraparib huwa sottostrat ta' carboxylesterases (CEs) u UDP-glucuronosyltransferases (UGTs) in vivo.
English: In pooled samples collected over 6 days, 40.0 % of the dose was recovered in the urine primarily as metabolites and 31.6 % of the dose was recovered in the feces primarily as unchanged niraparib.
Maltese: F'kampjuni raggruppati miġbura fuq 6 ijiem, 40.0 % tad-doża ġiet irkuprata fl-awrina primarjament bħala metaboliti u 31.6 % tad-doża ġiet irkuprata fl-ippurgar primarjament bħala niraparib mhux mibdul.
English: placebo (N = 116)
Maltese: (N = 116)
English: Neither niraparib nor M1 is a substrate of organic anion transport polypeptide 1B1 (OATP1B1), 1B3 (OATP1B3), or organic cation transporter 1 (OCT1).
Maltese: La niraparib u lanqas M1 m'huma sottostrati tal-polypeptide trasportanti anijoniku organiku 1B1 (OATP1B1), 1B3 (OATP1B3), jew tat-trasportatur katjoniku organiku 1 (OCT1).
English: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients who received Zejula or placebo.
Maltese: Ġew irrappurtati sindrome majelodisplastiku/lewkimja majelojde akuta (Myelodysplastic syndrome/acute myeloid leukaemia, MDS/AML), inkluż każijiet b'riżultat fatali, f'numru żgħir ta' pazjenti li rċivew Zejula jew il-plaċebo.
English: Niraparib was not mutagenic in a bacterial reverse mutation assay (Ames) test but was clastogenic in an in vitro mammalian chromosomal aberration assay and in an in vivo rat bone marrow micronucleus assay.
Maltese: Niraparib ma kienx mutaġeniku f'test ta' assaġġ ta' mutazzjoni riversiva ta' batterji (Ames) iżda kien klastoġeniku f'assaġġ ta' aberrazzjoni kromożomika tal-mammiferi in vitro u f'assaġġ tal-mikronukleu tal-mudullun tal-ġurdien in vivo.
English: Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the niraparib and placebo arms in the gBRCAmut (n = 203) and the non-gBRCAmut cohorts (n = 350).
Maltese: Id-demografiċi, il-karatteristiċi tal-marda tal-linja bażi u l-istorja ta' kura preċedenti kienu ġeneralment ibbilanċjati tajjeb bejn il-fergħat ta' niraparib u tal-plaċebo fil-koorti gBRCAmut (n = 203) u l-koorti non-gBRCAmut (n = 350).
English: Following a single-dose administration of 300 mg niraparib under fasting conditions, niraparib was measurable in plasma within 30 minutes and the mean peak plasma concentration (Cmax) for niraparib was reached in about 3 hours [804 ng/mL (% CV:50.2 %)].
Maltese: Wara għoti ta' doża waħda ta' 300 mg niraparib taħt kondizzjonijiet ta' sawm, niraparib tkejjel filplażma fi żmien 30 minuta u l-konċentrazzjoni massima (Cmax) medja tal-plażma għal niraparib intlaħqet f'madwar 3 sigħat [804 ng/mL (% CV:50.2 %)].
English: Back pain, arthralgia, myalgia
Maltese: Mhux komuni Uġigħ fid-dahar, artralġja, majalġja
English: Increased plasma concentrations of co-administered medicinal products that are substrates of these transporters (e.g. metformin) cannot be excluded.
Maltese: Ma jistgħux jiġu esklużi konċentrazzjonijiet fil-plażma miżjuda ta' prodotti mediċinali mogħtija flimkien li huma sottostrati ta' dawn it-trasportaturi (eż. metmorfin).
English: How to take Zejula
Maltese: X'fih Zejula
English: The study met its primary objective of statistically significantly improved PFS for niraparib maintenance monotherapy compared with placebo in the gBRCAmut cohort (HR 0.27; 95 % CI* 0.173, 0.410; p < 0.0001) as well as in the overall non-gBRCAmut cohort (HR 0.45; 95 % CI* 0.338, 0.607; p < 0.0001).
Maltese: 410; p < 0.0001) kif ukoll fil-koorti globali non-gBRCAmut (HR 0.45; 95 % CI* 0.338, 0.607; p < 0.0001).
English: In the clinical programme, thrombocytopenia was managed with laboratory monitoring, dose modification and platelet transfusion where appropriate (see section 4.2).
Maltese: Fil-programm kliniku, ittromboċitopenja ġiet immaniġġjata permezz ta' monitoraġġ tal-laboratorju, modifikazzjoni fid-doża u trasfużjoni tal-plejtlits fejn xieraq (ara sezzjoni 4.2).
English: • Pink eye
Maltese: • Għajn roża
English: Inhibition of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1) Neither niraparib nor M1 is an inhibitor of organic anion transport polypeptide 1B1 (OATP1B1) or 1B3 (OATP1B3).
Maltese: L-inibizzjoni ta' trasportaturi ta' assorbiment mill-fwied (OATP1B1, OATP1B3, u OCT1) La niraparib u lanqas M1 m'huma inibituri ta' polypeptide ta' trasport anijoniku organiku 1B1 (OATP1B1) jew 1B3 (OATP1B3).
English: CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered Zejula 100 mg/day
Maltese: Reazzjoni avversa ta' CTCAE* ≥ Grad 3 relatata mal-kura li ddum aktar minn 28 jum waqt li l-pazjent ikun qed jingħata Zejula 100 mg/jum
English: The median time to onset of neutropenia of any grade was 27 days, and 29 days for Grade 3/4 events.
Maltese: Iż-żmien medjan għall-bidu ta' newtropenja ta' kwalunkwe grad kien ta' 27 jum u ta' 29 jum għal avvenimenti ta' Grad 3/4.
English: Approximately 60 % of patients receiving Zejula experienced thrombocytopenia of any grade, and 34 % of patients experienced Grade 3/4 thrombocytopenia.
Maltese: Madwar 60 % tal-pazjenti li kienu qed jirċievu Zejula esperjenzaw tromboċitopenja ta' kwalunkwe grad, u 34 % tal-pazjenti esperjenzaw tromboċitopenja ta' Grad 3/4.
English: • Abnormal blood tests
Maltese: • Testijiet tad-demm anormali
English: In patients with baseline platelet count less than 180 × 109/L, thrombocytopenia of any grade and Grade 3/4 occurred in 76 % and 45 % of the patients, respectively.
Maltese: F'pazjenti b'għadd tal-plejtlits fillinja bażi ta' inqas minn 180 × 109/L, tromboċitopenja ta' kwalunkwe grad u ta' Grad 3/4 seħħet f'76 % u f'45 % tal-pazjenti, rispettivament.
English: Patients began treatment on Cycle 1/Day 1 (C1/D1) with niraparib 300 mg or matched placebo administered QD in continuous 28-day cycles.
Maltese: Il-pazjenti bdew il-kura f'Ċiklu 1/Jum 1 (C1/D1) b'niraparib 300 mg jew tqabblu għal plaċebo mogħti QD f'ċikli kontinwi ta' 28 jum.
English: Following a single oral 300-mg dose of niraparib, the mean terminal half-life (t½) of niraparib ranged from 48 to 51 hours (approximately 2 days).
Maltese: Wara doża orali ta' 300 mg ta' niraparib, in-nofs ħajja terminali medja (t½) ta' niraparib, varjat minn 48 sa 51 siegħa (madwar jumejn).
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OAT1 (e.g. probenecid) or OAT3 (e.g. probenecid, diclofenac), or OCT2 (e.g. cimetidine, quinidine) uptake transporters.
Maltese: Mhu meħtieġ l-ebda aġġustament fid-doża għal Zejula meta jingħata flimkien ma' prodotti mediċinali magħrufa li jinibixxu t-trasportaturi tal-assorbiment OAT1 (eż. probenecid) jew OAT3 (eż. probenecid, diclofenac), jew OCT2 (eż. cimetidine, quinidine).
English: TESARO Bio Spain S.L.U
Maltese: España TESARO Bio Spain S.
English: Niraparib as a substrate of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 is a substrate of organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Maltese: Niraparib bħala sottostrat ta' trasportaturi tal-assorbiment mill-kliewi (OAT1, OAT3, u OCT2) La niraparib u lanqas M1 m'huma sottostrati tat-trasportatur anijoniku organiku 1 (OAT1), 3 (OAT3), u tat-trasportatur katjoniku organiku 2 (OCT2).
English: Hard capsule of approximately 22 mm × 8 mm; white body with “100 mg” printed in black ink and purple cap with “Niraparib” printed in white ink.
Maltese: Kapsula iebsa ta' madwar 22 mm × 8 mm; korp abjad b' “100 mg” stampata b'linka sewda u għatu vjola b'“Niraparib” stampata b'linka bajda.
English: • Feeling of worry, nervousness, or unease
Maltese: • Tħossok inkwetata, nervuża jew skomda
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE ZEJULA
English: The major primary metabolite M1 does not appear to be an inhibitor of P-gp, BCRP, BSEP, or MATE1/2.
Maltese: L-inibizzjoni ta' trasportaturi tal-effluss (P-gp, BCRP, BSEP u MATE1/2)
English: Frequency of all CTCAE grades
Maltese: Frekwenza tal-gradi CTCAE kollha
English: Thrombocytopenia
Maltese: Konklużjonijiet xjentifiċi
English: Hypertension, including hypertensive crisis, has been reported with Zejula therapy.
Maltese: Ġiet irrappurtata l-ipertensjoni, inkluż kriżi ipertensiva, b'terapija b'Zejula.
English: The following adverse reactions have been identified in the ENGOT-OV16 study in patients receiving Zejula monotherapy (see Table 3).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew identifikati fl-istudju ENGOT-OV16 f'pazjenti li kienu qed jirċievu monoterapija b'Zejula (ara Tabella 3).
English: Neutropenia
Maltese: Ipertensjoni
English: Median (95 % CI) - mo
Maltese: Sopravivenza mingħajr progressjoni 2 Medjan (95 % CI) - mo
English: Hazard ratio (95 % CI) *CI denotes confidence interval, gBRCAmut germline BRCA mutation, and NR not reached
Maltese: Proporzjon ta' periklu (95 % CI) *CI tfisser intervall ta' kunfidenza, mutazzjoni BRCA ġerminali gBRCAmut, u NR mhux milħuq
English: Niraparib is a type of anti-cancer medicine called a PARP inhibitor.
Maltese: Niraparib huwa tip ta' mediċina kontra l-kanċer li tissejjaħ inibitur ta' PARP.
English: Also contains lactose and tartrazine (E 102).
Maltese: TA' EĊĊIPJENTI Fih ukoll lactose u tartrazine (E 102).
English: More patients in the niraparib group continued treatment for more than 12 months than patients in the placebo group (34.2 % and 21.1 %, respectively).
Maltese: Aktar pazjenti fil-grupp ta' niraparib komplew il-kura għal aktar minn 12-il xahar milli l-pazjenti fil-grupp tal-plaċebo (34.2 % u 21.1 %, rispettivament).
English: In the gBRCAmut cohort, the median number of treatment cycles was higher in the niraparib arm than the placebo arm (14 and 7 cycles, respectively).
Maltese: Fil-koorti gBRCAmut, in-numru medjan ta' ċikli ta' kura kien ogħla fil-fergħa ta' niraparib milli filfergħa tal-plaċebo (14 u 7 ċikli, rispettivament).
English: Therefore, caution is recommended when niraparib is combined with active substances the metabolism of which is CYP1A2-dependent and, notably, those having a narrow therapeutic range (e.g. clozapine, theophylline, and ropinirole).
Maltese: Għalhekk, hija rakkomandata l-kawtela meta niraparib jiġi kkombinat ma' sustanzi attivi li l-metaboliżmu tagħhom ikun dipendenti fuq CYP1A2 u, notevolment, dawk li jkollhom medda terapewtika dejqa (eż. clozapine, theophylline, u ropinirole).
English: AST increased, ALT increased, blood alkaline phosphatase increased
Maltese: Mhux komuni Żieda fl-AST, żieda fl-ALT, żieda fl-alkaline phosphatase fid-demm
English: In mice, single doses of niraparib increased intracellular levels of dopamine and metabolites in cortex.
Maltese: Fil-ġrieden, dożi waħidhom ta' niraparib żiedu l-livelli intraċellulari ta' dopamine u l-metaboliti fil-kortiċi.
English: The median duration of thrombocytopenia events of any grade was 23 days, and the median duration of Grade 3/4 thrombocytopenia was 10 days.
Maltese: Id-durata medjana ta' avvenimenti ta' tromboċitopenja ta' kwalunkwe grad kienet ta' 23 jum, u d-durata medjana ta' tromboċitopenja ta' Grad 3/4 kienet ta' 10 ijiem.
English: Due to the risk of thrombocytopenia, anticoagulants and medicinal products known to reduce the thrombocyte count should be used with caution (see section 4.8).
Maltese: Minħabba r-riskju ta' tromboċitopenja, antikoagulanti u prodotti mediċinali li huma magħrufin li jnaqqsu l-għadd tat-tromboċiti għandhom jintużaw b'kawtela (ara sezzjoni 4.8).
English: Palpitations
Maltese: Tromboċitopenja
English: The cases were typical of secondary, cancer therapy-related MDS/AML.
Maltese: Il-każijiet kienu tipikament ta' MDS/AML sekondarji relatati mat-terapija tal-kanċer.
English: • For patients with platelet count ≤ 10,000/μL, platelet transfusion should be considered.
Maltese: • Għal pazjenti bl-għadd tal-plejtlits ≤ 10,000/μL, għandha tiġi kkunsidrata trasfużjoni tal-plejtlits.
English: • Inflammation of the mouth and/or digestive tract
Maltese: • Infjammazzjoni tal-ħalq u/jew tas-sistema diġestiva
English: Estimated Survival Function
Maltese: Informazzjoni għall-pazjent
English: • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥ 1,500/µL or haemoglobin returns to ≥ 9 g/dL.
Maltese: • Waqqaf Zejula għal massimu ta' 28 jum u mmonitorja l-għadd tad-demm kull ġimgħa sakemm l-għadd tannewtrofili jirritorna għal ≥ 1,500/µL jew tal-emoglobina jirritorna għal ≥ 9 g/dL.
English: Pancytopenia, febrile neutropenia
Maltese: Panċitopenja, newtropenja bid deni
English: HR (95% CI)
Maltese: Proporzjon ta' periklu (95 % CI)
English: In the clinical programme, neutropenia was managed with laboratory monitoring and dose modifications (see section 4.2).
Maltese: Fil-programm kliniku, in-newtropenja ġiet immaniġġjata permezz ta' monitoraġġ tal-laboratorju u modifikazzjonijiet fid-doża (ara sezzjoni 4.2).
English: More patients in the niraparib group continued treatment for more than 12 months than patients in the placebo group (54.4 % and 16.9 % respectively).
Maltese: Aktar pazjenti fil-grupp ta' niraparib komplew il-kura għal aktar minn 12-il xahar milli pazjenti fil-grupp tal-plaċebo (54.4 % u 16.9 %, rispettivament).
English: • Decreased appetite
Maltese: • Nuqqas ta' aptit
English: • Resume Zejula at a reduced dose (200 mg/day).
Maltese: Kompli Zejula mill-ġdid b'doża mnaqqsa (200 mg/jum).
English: In addition, Granulocyte-Colony Stimulating Factor (G-CSF) was administered to approximately 6 % of patients treated with niraparib as concomitant therapy for neutropenia.
Maltese: Barra minn hekk, ingħata Fattur Stimolanti tal-Kolonja tal-Granuloċiti (GCSF, Granulocyte-Colony Stimulating Factor) lil madwar 6 % tal-pazjenti kkurati b'niraparib bħala terapija konkomitanti għan-newtropenja.
English: • Nose bleed
Maltese: • Tħossok indebolita
English: Tachycardia
Maltese: • Stitikezza
English: The experimental test was not able to discriminate which patients would or would not benefit from niraparib maintenance therapy.
Maltese: It-test sperimentali ma setax jiddiskrimina liema pazjenti kienu jew ma kinux se jibbenefikaw minn terapija ta' manutenzjoni b'niraparib.
English: Each hard capsule shell also contains the colouring agent tartrazine (E 102) [0.0172 mg].
Maltese: Kull qoxra ta' kapsula iebsa fiha wkoll s-sustanza kuluranti tartrazine (E 102) [0.
English: The absolute bioavailability of niraparib is approximately 73 %, indicating minimal first pass effect.
Maltese: Il-bijodisponibbiltà assoluta ta' niraparib hija madwar 73 %, li tindika effett tal-ewwel passaġġ minimu.
English: Thrombocytopenia occurred more commonly in patients whose baseline platelet count was less than 180 × 109/L.
Maltese: It-tromboċitopenja kienet aktar akomuni f'pazjenti li l-għadd tagħhom tal-plejtlits fillinja bażi kien inqas minn 180 × 109/L.
English: Zejula hard capsules have a white opaque body and a purple opaque cap.
Maltese: Zejula kapsuli ibsin għandhom korp opak abjad u għatu opak vjola.
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of niraparib in paediatric patients.
Maltese: Ma sar l-ebda studju biex jiġu investigati l-farmakokinetiċi ta' niraparib f'pazjenti pedjatriċi.
English: Nausea, constipation, vomiting, abdominal pain, diarrhoea, dyspepsia
Maltese: Komuni ħafna Nawsja, stitikezza, remettar, uġigħ addominali, dijarea, dispepsja
English: • Dizziness
Maltese: • Remettar