FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL.
Maltese: Kull kunjett fih 200 mg ta' zanamivir (bħala idrat) f'20 mL.
English: This medicine contains 70.8 mg sodium (main component of cooking/table salt) in each vial.
Maltese: Din il-mediċina fiha 70.8 mg ta' sodju (il-komponent ewlieni tal-melħ tat-tisjir/tal-mejda) f'kull kunjett.
English: Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test Symptom onset 4 days subgroup, N Median TTCR, days
Maltese: Sottogrupp bil-bidu tas-sintomi ta' ≤4 ijiem, N TTCR Medjan, jiem
English: Cross-resistance between zanamivir and oseltamivir or peramivir has been observed in neuraminidase inhibition assays.
Maltese: Reżistenza inkroċjata bejn zanamivir u oseltamivir jew peramivir ġiet osservata f'assaġġi tal-inibizzjoni tannewraminidażi.
English: Hepatic impairment No dose modification is required (see section 5.2).
Maltese: Ma hija meħtieġa l-ebda modifika tad-doża (ara sezzjoni 5.2).
English: The most important serious adverse reaction was hepatocellular injury, observed in two patients (<1%).
Maltese: L-aktar reazzjoni avversa serja importanti kienet ħsara epatoċellulari, li kienet osservata f'żewġ pazjenti (<1%).
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH01
Maltese: L-istudji fuq l-annimali ma jindikawx effetti ta' ħsara diretti jew indiretti fir-rigward tat-tossiċità riproduttiva (ara sezzjoni 5.3).
English: • The volume of Dectova and total volume for infusion will depend on the patient's age, weight and renal function (see section 4.2).
Maltese: • Il-volum ta' Dectova u l-volum totali għall-infużjoni se jiddependu fuq l-età, il-piż u l-funzjoni tal kliewi tal-pazjent (ara sezzjoni 4.2).
English: • severe allergic reactions, including features such as itchy rash, swelling of the face, throat or tongue, breathing difficulty, light headedness and vomiting.
Maltese: • reazzjonijiet allerġiċi severi, b'karatteristiċi bħal raxx bil-ħakk, nefħa fil-wiċċ, fil-griżmejn jew fl ilsien, diffikultà fit-teħid tan-nifs, sturdament u rimettar.
English: 9.3 mg/kg twice daily
Maltese: 14 mg/kg 9.3 mg/kg darbtejn kuljum
English:  6 years to < 18 years
Maltese: ≥ 6 snin sa < 18-il sena
English: • Using a sterile needle and syringe, withdraw and discard a volume of sodium chloride 9 mg/mL
Maltese: • Bl-użu ta' labra sterili u siringa, iġbed u armi volum ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) ta' klorur tas-sodju (ekwivalenti għall-volum tal Dectova) mill-borża talinfużjoni.
English: Neuropsychiatric events, including seizures, delirium, hallucination and abnormal behaviour, have been reported during administration of zanamivir in patients with influenza, especially in children and adolescents.
Maltese: Kien hemm rapporti ta' avvenimenti newropsikjatriċi, fosthom aċċessjonijiet, delirju, alluċinazzjonijiet u mġiba anormali, waqt l-għoti ta' zanamivir f'pazjenti bl-influwenza, speċjalment fit-tfal u fl-adolexxenti.
English: Children Your doctor will decide on the correct dose of Dectova.
Maltese: It-tabib tiegħek se jiddeċiedi dwar id-doża korretta ta' Dectova.
English: 1114 AB Amsterdam-Duivendrecht Netherlands
Maltese: 1114 AB Amsterdam-Duivendrecht In-Netherlands
English: EU/1/17/1235/001 EU/1/17/1235/002 EU/1/17/1235/003
Maltese: EU/1/17/1235/002
English: *CTCAE=Common Terminology Criteria for Adverse Events
Maltese: *CTCAE=Kriterji Komuni tat-Terminoloġija għal Avvenimenti Avversi
English: • Permanently discontinue Zejula.
Maltese: • Waqqaf Zejula b'mod permanenti.
English: Neutrophil < 1,000/µL or Haemoglobin < 8 g/dL
Maltese: Newtrofili < 1,000/µL jew Emoglobina < 8 g/dL
English: Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4).
Maltese: Kull kapsula iebsa fiha 254.5 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: Capsule shell Titanium dioxide (E 171) Gelatin
Maltese: Qoxra tal-kapsula Titanium dioxide (E 171)
English: Date of first authorisation: 16 November 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 Novembru 2017
English: PFS median (95% CI*)
Maltese: PFS medjana (95 % CI*)
English: • The active substance is niraparib.
Maltese: • Is-sustanza attiva hi niraparib.
English: Non-gBRCAmut cohort niraparib (N = 138)
Maltese: koorti gBRCAmut Koorti non-gBRCAmut niraparib (N = 138)
English: Age, weight and race
Maltese: Età, piż u razza
English: 84 × 1 hard capsules 56 × 1 hard capsules 28 × 1 hard capsules
Maltese: 84 × 1 kapsuli ibsin 56 × 1 kapsuli ibsin 28 × 1 kapsuli ibsin
English: TESARO Bio GERMANY GmbH
Maltese: Deutschland TESARO Bio GERMANY GmbH
English: Shellac (E 904) Propylene glycol (E 1520) Potassium hydroxide (E 525) Black iron oxide (E 172) Sodium hydroxide (E 524) Povidone (E 1201)
Maltese: Propylene glycol (E 1520) Potassium hydroxide (E 525) Black iron oxide (E 172) Sodium hydroxide (E 524) Povidone (E 1201)
English: TESARO Bio Italy S.r.l.
Maltese: Italia TESARO Bio Italy S.r.l.
English: TESARO Bio Sweden AB
Maltese: Sverige TESARO Bio Sweden AB
English: Photosensitivity, rash
Maltese: Komuni Fotosensittività, raxx
English: Patients with ECOG performance status 2 to 4 Clinical data are not available in patients with ECOG performance status 2 to 4.
Maltese: Pazjenti bi status tal-prestazzjoni ECOG 2 sa 4 Mhix disponibbli dejta klinika f'pazjenti bi status tal-prestazzjoni ECOG 2 sa 4.
English: Platelet count < 100,000/μL
Maltese: Għadd tal-plejtlits < 100,000/μL
English: Repeat-dose toxicity
Maltese: Tossiċità ta' doża ripetuta
English: Induction of CYPs (CYP1A2 and CYP3A4)
Maltese: L-induzzjoni tas-CYPs (CYP1A2 u CYP3A4)
English: Oxidative metabolism of niraparib is minimal in vivo.
Maltese: Il-metaboliżmu ossidattiv ta' niraparib huwa minimu in vivo.
English: TESARO Bio France SAS
Maltese: France TESARO Bio France SAS
English: Endpoint
Maltese: End-point
English: • The other ingredients (excipients) are: capsule content: magnesium stearate, lactose monohydrate capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), erythrosine (E 127), tartrazine (E 102) printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), sodium hydroxide (E 524), and povidone (E 1201).
Maltese: • Is-sustanzi mhux attivi (eċċipjenti) l-oħra huma: kontenut tal-kapsula: magnesium stearate, lactose monohydrate kapsula: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), erythrosine (E 127), tartrazine (E 102) inka tal-istampar: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), sodium hydroxide (E 524), u povidone (E 1201).
English: Table 4: Summary of primary objective outcomes in the ENGOT-OV16 study gBRCAmut cohort
Maltese: Tabella 4: Sommarju tar-riżultati tal-objettiv primarju fl-istudju ENGOT-OV16
English: In the clinical programme, hypertension was readily managed with anti-hypertensive medicinal products.
Maltese: Fil-programm kliniku, l-ipertensjoni ġiet immaniġġjata faċilment bi prodotti mediċinali anti-ipertensivi.
English: M1 is not a CYP1A2 inducer.
Maltese: M1 mhuwiex induttur ta' CYP1A2.
English: See leaflet for further information.
Maltese: Sorsi oħra ta᾽ informazzjoni
English: Frequency of CTCAE grade 3 or 4
Maltese: Frekwenza tal-grad CTCAE 3
English: Zejula 100 mg hard capsules
Maltese: Zejula 100 mg kapsuli ibsin
English: Frequencies of occurrence of undesirable effects 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 < 1/1,000); very rare (< 1/10,000).
Maltese: Il-frekwenzi tal-okkorrenzza ta' effetti mhux mixtieqa hija definita 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).
English: Zejula contains tartrazine (E 102)
Maltese: Zejula fih tartrazine (E 102)
English: Aclar/PVC/aluminium foil perforated unit dose blisters in cartons of 84 × 1, 56 × 1 and 28 × 1 hard capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' doża waħda perforati tal-Aclar/PVC/fojl tal-aluminju f'kartuni ta' 84 × 1, 56 × 1 u 28 × 1 kapsuli ibsin.
English: Table 5: Secondary endpoints*
Maltese: Punti aħħarin sekondarji*
English: Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair.
Maltese: Niraparib huwa inibitur tal-enzima poli(ADP-ribose) polymerase (PARP), PARP-1 u PARP-2, li għandhom irwol fil-fejqan tad-DNA.
English: There are limited clinical data in patients aged 75 or over.
Maltese: Hemm dejta klinika limitata f'pazjenti li għandhom 75 sena jew aktar.
English: Children under 18 years of age should not be given Zejula.
Maltese: Tfal taħt l-età ta' 18-il sena m'għandhomx jingħataw Zejula.
English: Zejula 100 mg capsules niraparib
Maltese: Zejula 100 mg kapsuli ibsin niraparib
English: Febrile neutropenia was reported in 2 out of 367 patients in the NOVA trial leading to the frequency uncommon.
Maltese: Newtropenja biddeni ġiet irrappurtata fi 2 minn 367 pazjent fil-prova klinika NOVA li wasslet għall-frekwenza mhux komuni.
English: Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.
Maltese: Kull kapsula iebsa fiha niraparib tosylate monohydrate ekwivalenti għal 100 mg niraparib.
English: Niraparib is metabolised primarily by carboxylesterases (CEs) to form a major inactive metabolite, M1.
Maltese: Niraparib ġie primarjament metabolizzat minn carboxylesterases (CEs) biex jifforma metabolit inattiv maġġuri, M1.
English: Neither niraparib nor M1 is a CYP3A4 inducer in vitro.
Maltese: La niraparib u lanqas M1 m'huma indutturi ta' CYP3A4 in vitro.
English: Radioactive recovery in the urine accounted for 47.5 % (range 33.4 % to 60.2 %) and in the feces for 38.8 % (range 28.3 % to 47.0 %) of the dose.
Maltese: L-irkupru radjuattiv fl-awrina kien jammonta għal 47.5 % (medda 33.4 % sa 60.2 %) u fl-ippurgar għal 38.8 % (medda 28.3 % sa 47.0
English: Zejula contains the active substance niraparib.
Maltese: Zejula fih is-sustanza attiva niraparib.
English: Patients could not have received prior PARP inhibitor therapy, including Zejula.
Maltese: Il-pazjenti ma setgħux kienu rċievu terapija b'inibitur ta' PARP preċedenti, inkluż Zejula.
English: Most patients were age 18 to 64 years (78 %), Caucasian (86 %) and had an ECOG performance status of 0 (68 %).
Maltese: Ħafna mill-pazjenti kellhom 18 sa 64 sena (78 %), kienu Kawkasi (86 %) u kellhom status tal-prestazzjoni ECOG ta' 0 (68 %).
English: PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP).
Maltese: L-inibituri ta' PARP jimblukkaw enzima li tissejjaħ poly [adenosine diphosphateribose] polymerase (PARP).
English: Progression-free survival was determined per RECIST (Response Evaluation Criteria in Solid Tumors, version 1.1) or clinical signs and symptoms and increased CA-125.
Maltese: Is-sopravivenza mingħajr progressjoni ġie determinat skont RECIST (Kriterji ta' Evalwazzjoni tarReazzjoni f'Tumuri Solidi, Response Evaluation Criteria in Solid Tumors v1.1) jew minn sinjali u sintomi kliniċi u CA-125 miżjud.
English: Niraparib was moderately protein bound in human plasma (83.0 %), mainly with serum albumin.
Maltese: Niraparib kien moderatament marbut mal-proteini fil-plażma tal-bniedem (83.0 %), prinċipalment b'albumina fis-seru.
English: In vitro, niraparib inhibits P-gp very weakly and BCRP with an IC50 = 161 µM and 5.8 µM, respectively.
Maltese: In vitro, niraparib jinibixxi P-gp b'mod dgħajjef ħafna u BCRP b'IC50 = 161 µM u 5.8 µM, rispettivament.
English: In the population pharmacokinetic analysis of data from clinical studies in patients, pre-existing mild (CLCr < 90 - ≥ 60 ml/min) and moderate (CLCr < 60 - ≥ 30 mL/min) renal impairment did not influence the clearance of niraparib.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji kliniċi fil-pazjenti, indeboliment talkliewi ħafif (CLCr < 90 - ≥ 60 ml/min) u moderat (CLCr < 60 - ≥ 30 mL/min) pre-eżistenti ma affettwax l-eliminazzjoni ta' niraparib.
English: In the HRDneg group, the hazard ratio was 0.58 (95 % CI, 0.361, 0.922; p = 0.0226).
Maltese: Fil-grupp HRDneg, il-proporzjon ta' periklu kien 0.58 (95 % CI, 0.361, 0.922; p = 0.0226).
English: In a population pharmacokinetic analysis of niraparib, the Vd/F was 1,074 L in cancer patients, indicating extensive tissue distribution of niraparib.
Maltese: F'analiżi farmakokineta tal-popolazzjoni ta' niraparib, il-Vd/F kien ta' 1,074 L f'pazjenti tal-kanċer, li jindika distribuzzjoni estensiva tat-tessut ta' niraparib.
English: Effect of other medicinal products on niraparib
Maltese: L-effett ta' prodotti mediċinali oħra fuq niraparib
English: A sensitivity analysis of investigator PFS showed the following results for the gBRCAmut cohort: HR 0.27 (95 % CI*, 0.182, 0.401; p < 0.0001); median PFS 14.8 months (95% CI*, 12.0, 16.6) for niraparib and median PFS 5.5 months (95% CI*, 4.9, 7.2) for placebo, and for the non-gBRCAmut cohort: HR 0.53 (95 % CI*, 0.405, 0.683; p < 0.0001); median PFS 8.7 months (95 % CI*, 7.3, 10.0) for niraparib and median PFS 4.3 months (95% CI*, 3.7, 5.5) for placebo.
Maltese: HR 0.27 (95 % CI*, 0.182, 0.401; p < 0.0001); PFS medjana 14.8 xhur (95 % CI*, 12.0, 16.6) għal niraparib u PFS medjana 5.5 xhur (95 % CI*, 4.9, 7.2) għall-plaċebo, u għall-koorti non-gBRCAmut cohort:
English: There are no clinical data on fertility.
Maltese: M'hemmx dejta klinika dwar il-fertilità.
English: Overall, MDS/AML has been reported in 7 out of 751 (0.9 %) patients treated with Zejula in clinical studies.
Maltese: B'mod globali, MDS/AML ġew irrappurtati f'7 minn 751 (0.9 %) pazjent ikkurati b'Zejula fl-istudji klinċi.
English: Table 4 shows the results for the PFS primary endpoint for the primary efficacy populations (gBRCAmut cohort and the overall non-gBRCAmut cohort).
Maltese: Tabella 4 turi r-riżultati għall-punt aħħari primarju tal-PFS għallpopolazzjonijiet tal-effikaċja primarja (koorti gBRCAmut u l-koorti globali non-gBRCAmut).
English: Inhibition of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) Neither niraparib nor M1 is an inhibitor of any active substance-metabolising CYP enzymes, namely CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5.
Maltese: La niraparib u lanqas M1 m'huma inibituri ta' xi enzima tas-CYP li timmetabolizza s-sustanza attiva, prinċipalment CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, u CYP3A4/5.
English: A high proportion of patients in both treatment arms in both cohorts had received 3 or more prior lines of chemotherapy, including 49 % and 34 % of niraparib patients in the gBRCAmut and non-gBRCAmut cohorts, respectively.
Maltese: Proporzjon għoli ta' pazjenti fiż-żewġ fergħat ta' kura fiż-żewġ koorti kienu rċivew 3 linji preċedenti ta' kimoterapija jew aktar, inkluż 49 % u 34 % ta' pazjenti ta' niraparib fil-koorti gBRCAmut u ta' non-gBRCAmut, rispettivament.
English: In vitro, niraparib weakly inhibits the organic cation transporter 1 (OCT1) with an IC50 = 34.4 µM.
Maltese: In vitro, niraparib jinibixxi b'mod dgħajjef it-trasportatur katjoniku organiku 1 (OCT1) b'IC50 = 34.4 µM.
English: • 56 × 1 hard capsules
Maltese: • 56 × 1 kapsuli ibsin
English: ≥ 100,000/µL.
Maltese: 0172 mg].
English: Grade 3/4 hypertension occurred in 8.2 % of patients.
Maltese: Kien hemm ipertensjoni ta' Grad 3/4 f'8.2 % tal-pazjenti.
English: Pancytopenia has been observed in < 1 % of patients receiving niraparib.
Maltese: Panċitopenja ġiet osservata f'< 1 % tal-pazjenti li kienu qed jirċievu niraparib.
English: Thrombocytopenia, anaemia, neutropenia
Maltese: Tromboċitopenja, anemija, newtropenja
English: The secondary endpoints CFI, TFST, and PFS2 demonstrated a statistically significant and persistent treatment effect in favour of the niraparib treatment arm in the gBRCAmut cohort and the overall non-gBRCAmut cohort (Table 5).
Maltese: Il-punti aħħarin sekondarji CFI, TFST, u PFS2 urew effett tal-kura statistikament sinifikant u persistenti favur tal-fergħa ta' kura ta' niraparib fl-koorti gBRCAmut u fil-koorti globali nongBRCAmut (Tabella 5).
English: Figure 1: Kaplan-Meier plot for progression-free survival in the gBRCAmut cohort based on IRC assessment (ITT population, N = 203)
Maltese: Figura 1: Plott ta' Kaplan-Meier għal sopravivenza mingħajr progressjoni fil-koorti gBRCAmut abbażi tal-valutazzjoni IRC (popolazzjoni ITT, N = 203)
English: Secondary efficacy endpoints included chemotherapy-free interval (CFI), time to first subsequent therapy (TFST), PFS after the first subsequent therapy (PFS2), time to second subsequent therapy (TSST) and OS (overall survival).
Maltese: Il-punti aħħarin tal-effikaċja sekondarji kienu jinkludu intervall mingħajr kimoterapija (CFI, chemotherapy-free interval), iż-żmien għall-ewwel terapija sussegwenti (TFST, time to first subsequent therapy), PFS wara l-ewwel terapija sussegwenti (PFS2), iż-żmien għat-tieni terapija sussegwenti(TSST, time to second subsequent therapy) u l-OS (sopravivenza globali, overall survival).
English: Zejula hard capsules contain lactose monohydrate.
Maltese: Kontenut tal-kapsula Magnesium stearate Lactose monohydrate
English: Table 3: Adverse drug reactions: frequencies based on all-causality adverse events* System Organ Class
Maltese: Tabella 3: Reazzjonijiet avversi għall-mediċina: frekwenzi bbażati fuq avvenimenti avversi ta' kull tip*
English: Urinary tract infection, bronchitis
Maltese: Infezzjoni fl-apparat tal-awrina, bronkite
English: ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Maltese: Dijanjożi kkonfermata ta' sindrome majelodisplastiku (MDS, myelodysplastic syndrome) jew ta' lewkimja majelojde akuta (AML, acute myeloid leukaemia)
English: In the HRDpos group, the hazard ratio was 0.38 (95 % CI, 0.243, 0.586; p < 0.0001).
Maltese: Fil-grupp HRDpoż, il-proporzjon ta' periklu kien 0.38 (95 % CI, 0.243, 0.586; p < 0.0001).
English: Following a signal regarding sepsis with niraparib, a number of relevant cases were identified.
Maltese: Wara sinjal dwar sepsis b'niraparib, ġew identifikati numru ta' każijiet rilevanti.
English: This medicine has not been studied in this age group.
Maltese: Din il-mediċina ma ġietx ittestjata f'dan il-grupp ta' età.
English: Approximately 25 % of patients in the NOVA study weighed less than 58 kg, and approximately 25 % of patients weighed more than 77 kg.
Maltese: Madwar 25 % tal-pazjenti fl-istudju NOVA kienu jiżnu inqas minn 58 kg, u madwar 25 % tal-pazjenti kienu jiżnu aktar minn 77 kg.
English: In the pivotal Phase 3 international trial (ENGOT-OV16), the incidence of MDS/AML in patients who received niraparib (1.4 %) was similar to that in patients who received placebo (1.1 %).
Maltese: Fil-prova pivotali ta' Fażi 3 internazzjonali (ENGOT-OV16), l-inċidenza ta' MDS/AML f'pazjenti li rċivew niraparib (1.4 %) kienet simili għal dik f'pazjenti li rċivew il-plaċebo (1.1 %).
English: Bronchitis, conjunctivitis
Maltese: Bronkite, konġuntivite
English: • 84 × 1 hard capsules
Maltese: • 84 × 1 kapsuli ibsin
English: In the NOVA study, 48 of 367 (13 %) of patients experienced bleeding with concurrent thrombocytopenia; all bleeding events concurrent with thrombocytopenia were Grade 1 or 2 in severity except for one event of Grade 3 petechiae and haematoma observed concurrently with a serious adverse event of pancytopenia.
Maltese: Fl-istudju NOVA, 48 minn 367 (13 %) tal-pazjenti esperjenzaw fsada bi tromboċitopenja konkurrenti; lavvenimenti kollha ta' fsada konkurrenti mat-tromboċitopenja kienu ta' Grad 1 jew 2 fis-severità ħlief avveniment wieħed ta' tbenġil u ematoma ta' Grad 3 osservat flimkien ma' avveniment avvers serju ta' panċitopenja.
English: In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib was 16.2 L/h in cancer patients.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni, it-tneħħija totali apparenti (CL/F) ta' niraparib kienet ta' 16.2 L/h f'pazjenti tal-kanċer.
English: • 28 × 1 hard capsules
Maltese: • 28 × 1 kapsuli ibsin
English: In the NOVA study, patients eligible for Zejula therapy had the following baseline haematologic parameters: absolute neutrophil count (ANC) ≥ 1,500 cells/µL; platelets ≥ 100,000 cells/µL and haemoglobin ≥ 9 g/dL prior to therapy.
Maltese: Fl-istudju NOVA, il-pazjenti eliġibbli għal terapija b'Zejula kellhom il-parametri ematoloġiċi fil-linja bażi li ġejjin: għadd assolut tan-newtrofili (ANC, absolute neutrophil count) ≥ 1,500 ċellula/µL; plejtlits ≥ 100,000 ċellula/µL u emoglobina ≥ 9 g/dL qabel it-terapija.
English: The median duration of anaemia of any grade was 63 days, and 8 days for Grade 3/4 events.
Maltese: Id-durata medjana tal-anemija ta' kwalunkwe grad kienet ta' 63 jum, u ta' 8 ijiem għal avvenimenti ta' Grad 3/4.
English: This medicinal product contains tartrazine (E 102), which may cause allergic reactions.
Maltese: Dan il-prodott mediċinali fih tartrazine (E 102), li jista' jikkawża reazzjonijiet allerġiċi.
English: The CA-125 levels should be normal (or a > 90 % decrease in CA-125 from baseline) following their last platinum treatment, and be stable for at least 7 days.
Maltese: CA-125 għandhom ikunu normali (jew nuqqas ta' > 90 % f'CA-125 mil-linja bażi) wara l-aħħar kura tiegħu bil-platinu, u għandu jkun stabbli għal tal-inqas 7 ijiem.
English: Niraparib as a substrate of efflux transporters (P-gp, BCRP, and MATE1/2) Niraparib is a substrate of P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).
Maltese: Niraparib huwa sottostrat ta' P-glycoprotein (P-gp) u ta' Proteina ta' Reżistenza għall-Kanċer tas-Sider (BCRP, Breast Cancer Resistance Protein (BCRP)).
English: Approximately 50 % of patients experienced anaemia of any grade, and 25 % experienced Grade 3/4 anaemia.
Maltese: Madwar 50 % tal-pazjenti esperjenzaw anemija ta' xi grad, u 25 % esperjenzaw anemija ta' Grad 3/4.
English: Niraparib is not a substrate of bile salt export pump (BSEP).
Maltese: Niraparib mhuwiex sottostrat tal-pompa ta' esportazzjoni tal-melħ tal-bila (BSEP, bile salt export pump).
English: Chemotherapy-free interval Median (95 % CI) - mo
Maltese: Intervall mingħajr kimoterapija Medjan (95 % CI) - mo
English: (Nir:plac) (95 % CI*) * CI denotes confidence interval.
Maltese: Proporzjon ta' periklu (HR, Hazard ratio) (Nir:plaċ) (95 % CI*) *CI tfisser intervall ta' kunfidenza.
English: Figure 2: Kaplan-Meier plot for progression-free survival in the non-gBRCAmut cohort overall based on IRC assessment (ITT population, N = 350)
Maltese: Figura 2: Plott ta' Kaplan-Meier għal sopravivenza mingħajr progressjoni fil-koorti nongBRCAmut abbażi tal-valutazzjoni IRC (popolazzjoni ITT, N = 350)
English: The median time to onset of thrombocytopenia regardless of grade and Grade 3/4 thrombocytopenia was 22 and 23 days, respectively.
Maltese: Iż-żmien medjan għall-bidu tat-tromboċitopenja irrispettivament mill-grad u tat-tromboċitopenja ta' Grad 3/4 kien ta' 22 u ta' 23 jum, rispettivament.
English: Caution is then recommended when niraparib is combined with substrates of BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin, and methotrexate).
Maltese: Hija rakkomandata l-kawtela meta niraparib jiġi kkombinat ma' sottostrati ta' BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin, u methotrexate).
English: Following an oral administration of a single 300-mg dose of [14C]-niraparib, on average 86.2 % (range 71 % to 91 %) of the dose was recovered in urine and feces over 21 days.
Maltese: Wara għoti orali ta' doża waħda ta' 300 mg ta' [14C]-niraparib, bħala medja, 86.2 % (medda 71 % sa 91 %) tad-doża ġie rkuprat fl-awrina u fl-ippurgar fuq 21 jum.
English: The median time to onset of anaemia of any grade was 42 days, and 85 days for Grade 3/4 events.
Maltese: Iż-żmien medjan għall-bidu ta' anemija ta' kwalunkwe grad kien ta' 42 jum, u ta' 85 jum għal avvenimenti ta' Grad 3/4.