FrancophonIA/ELRC3.0 huggingface dataset:
English: ARIEL2 population characteristics in 64 patients were: median age 60 years (range 33 to 80), white(75%), ECOG performance status 0 (61%) or 1 (39%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (78%), median time since ovarian cancer diagnosis 53 months [range: 22-197], median progression-free interval from the last platinum treatment 7.6 months [range:
Maltese: Il-karatteristiċi tal-popolazzjoni f'ARIEL2 f'64 pazjent kienu: medjan ta' età ta' 60 sena (medda 33 sa 80), bojod (75%), stat ta' prestazzjoni tal-Eastern Cooperative Oncology Group (ECOG) 0 (61%) jew 1 (39%), kanċer tal-ovarji ta' grad għoli (100%), 3 jew aktar korsijiet ta' kimoterapija fil-passat (78%), żmien medjan mid-dijanjosi ta' kanċer tal-ovarji (53 xahar [medda: 22 - 197]), intervall medjan mingħajr progressjoni mill-aħħar trattament bil-platinu 7.6 xhur [medda: 0.7 - 26.5].
English: • medicines to lower blood cholesterol levels- such as rosuvastatin
Maltese: • mediċini biex ibaxxu l-livelli ta' kolesterol fid-demm - bħal rosuvastatin
English: Increases in serum creatinine, predominantly mild to moderate (CTCAE Grade 1 or 2), were observed in 20% of patients within the first few weeks of treatment with rucaparib.
Maltese: Żidiet fil-kreatinina fis-serum, predominantement minn ħfief sa moderati (CTCAE Grad 1 jew 2), kienu osservati f'20% tal-pazjenti fi żmien l-ewwel ftit ġimgħat tat-trattament b'rucaparib.
English: Rucaparib induced structural chromosomal aberrations in the in vitro human lymphocyte chromosomal aberration assay.
Maltese: Rucaparib induċa aberrazzjonijiet kromożomali strutturali fl-assaġġ tal-aberrazzjoni kromożomali tal-limfoċiti umani in vitro
English: HR (95% CI) p-valueb a. All randomised patients.
Maltese: HR (95% CI) valur pb a.
English: • high cholesterol levels
Maltese: • livelli għoljin ta' kolesterol
English: In an exploratory analysis in this subgroup, a response was noted in 18% (95% CI 12% - 26%) of patients (n=26) on rucaparib compared to 8% (95% CI 3% - 17%) of patients (n=5) on placebo (2-sided p-value = 0.0069), including 10 patients (7%) in the rucaparib group who achieved a complete remission.
Maltese: F'analiżi esploratorja f'dan is sottogrupp, ġie nnutat rispons fi 18 % (95% CI 12% - 26%) tal-pazejnti (n=26) fuq rucaparib meta mqabbel ma' 8 % (95% CI 3% - 17%) tal-pazjenti (n=5) fuq il-plaċebo (valur p miż-żewġ naħat =
English: Adverse reactions CTCAE Grade 3 or higher occurred in 23% (anaemia), 8% (neutropenia) and 6% (thrombocytopenia) of patients.
Maltese: Reazzjonijiet avversi ta' CTCAE Grad 3 jew ogħla seħħew fi 23% (anemija), 8% (newtropenija) u 6% (tromboċitopenija) tal-pazjenti.
English: • The usual recommended dose is 600 mg twice a day.
Maltese: • Id-doża rakkomandata normali hi ta' 600 mg darbtejn kuljum.
English: The tumour histology was high grade serous in 91.5% of patients, endometrioid in 2.8% and mixed histology in 4.7%.
Maltese: 5% tal-pazjenti, endometrijojde fi 2.8% u ta' isoloġija mħallta f'4.7%.
English: Continue rucaparib provided bilirubin is < ULN and alkaline phosphatase is < 3 x ULN
Maltese: < ULN u l-fosfatażi alkalina tkun < 3 x ULN
English: In vitro, rucaparib is an inhibitor of the BCRP and P-gp efflux transporters.
Maltese: In vitro, rucaparib hu inibitur tat-trasportaturi tal-effluss BCRP u P-gp. Inibizzjoni potenzjali in vivo ta' BCRP ma tistax tiġi eskluża.
English: Grade 3 without other signs of liver dysfunction Monitor LFTs weekly until resolution to Grade ≤ 2
Maltese: Grad 3 mingħajr sinjali oħra ta' disfunzjoni tal fwied
English: Elevations in serum creatinine
Maltese: Żidiet tal-kreatinina fis-serum
English: PFS assessed by blinded independent radiology review (BIR) was a key secondary efficacy outcome.
Maltese: Il-PFS kif evalwata minn reviżjoni ta' radjoloġija indipendenti blinded (BIR) kienet ir-riżultat tal-effikaċja sekondarja ewlenija.
English: Age, race, and body weight
Maltese: Età, razza, u piż tal-ġisem
English: The ORR, by independent radiology review for the platinum-sensitive population, was 42/79, 53.2% (95% CI [41.6-64.5]).
Maltese: 42/79, 53.2 (95% CI [41.6-64.5]).
English: Myelodysplastic syndrome/acute myeloid leukaemia
Maltese: Sindrome majelodisplastiku / Lewkimja majelojde akutaa
English: None of the patients had received prior treatment with a PARP inhibitor.
Maltese: L-ebda pazjent ma rċieva trattament preċedenti b'inibitur PARP.
English: Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e., preventative) use prior to starting Rubraca.
Maltese: Antiemetiċi, bħal antagonisti ta' 5-HT3, dexamethasone, aprepitant u fosaprepitant jistgħu jintużaw bħala trattament għad-dardir/rimettar u jistgħu wkoll jiġu kkunsidrati għal użu profilattiku (i.e., preventiv) qabel jinbeda Rubraca.
English: In patients with cancer following a high-fat meal, the Cmax increased by 20%, the AUC0-24h increased by 38%, and the Tmax was delayed by 2.5 hours, as compared with dosing under fasted conditions.
Maltese: xaħam, is-Cmax żdied b'20%, l-AUC0-24h żdied bi 38%, u t-Tmax kien ittardjat bi 2.5 sigħat, meta mqabbla ma' dożaġġ li ngħata f'kundizzjonijiet ta' sawm.
English: • medicines to treat irregular heartbeats - such as digoxin or quinidine
Maltese: • mediċini biex jittrattaw taħbit irregolari tal-qalb - bħal digoxin jew quinidine
English: No adjustment is recommended to the starting dose for elderly patients (≥ 65 years of age) (see sections 4.8 and 5.2).
Maltese: Ebda aġġustament mhu rakkomandat fid-doża tal-bidu għall-pazjenti anzjani (≥ 65 sena) (ara sezzjonijiet 4.8 u 5.2).
English: In patients with moderate renal impairment (CLcr of 30-59 mL/min), frequencies of some adverse reactions increased: Grade 3 or 4 anaemia (31%), Grade 3 or 4 thrombocytopenia (12%), and Grade 3 fatigue/asthenia (15%) were higher than in patients with mild renal impairment (CLcr > 59-80 mL/min) or normal renal function (CLcr > 80 mL/min) (21%, 5%, and 8%).
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi (CLcr ta' 30-59 mL/min), il-frekwenzi ta' xi reazzjonijiet avversi żdiedu: anemija ta' Grad 3 jew 4 (31%), tromboċitopenja ta' Grad 3 jew 4 (12%), u għeja/astenija ta' Grad 3 (15%) kienu ogħla milli f'pazjenti b'indeboliment ħafif tal-kliewi (CLcr
English: PAES: In order to further investigate the efficacy of rucaparib maintenance treatment in patients with relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy, the MAH should submit the final analysis of OS and updated analyses of PFS2, chemotherapy-free interval and time to start of subsequent anti-cancer treatment of the phase 3, randomised, double-blind study CO-338-014
Maltese: Sabiex tiġi investigata aktar l-effikaċja ta' trattament ta' manteniment b'rucaparib f'pazjenti b'kanċer tal-ovarji epiteljali, tat-tubi fallopjani, jew kanċer primarju tal-peritonew ta' grad għoli, rikadut, li jkunu f'rispons (sħiħ jew parzjali) għal kimoterapija bbażata fuq il-platinum, l-MAH għandu jippreżenta lanaliżi finali tal-OS u l-analiżijiet aġġornati tal-PFS2, intervall mingħajr kimoterapija u ż-żmien sal-bidu ta' trattament kontra l-kanċer sussegwenti talistudju ta' fażi 3, randomised, double-blind CO-338-014
English: The recommended dose is 600 mg rucaparib taken twice daily, equivalent to a total daily dose of 1,200 mg, until disease progression or unacceptable toxicity.
Maltese: Id-doża rakkomandata hija 600 mg rucaparib meħuda darbtejn kuljum, ekwivalenti għal doża totali ta' kuljum ta' 1,200 mg, sal-progressjoni tal-marda jew sakemm isseħħ tossiċità mhux aċċettabbli.
English: • Rubraca 200 mg film-coated tablets are blue, round, film-coated tablets with “C2” marked on one side.
Maltese: • Rubraca 200 mg pilloli miksija b'rita huma blu, tondi, pilloli miksija b'rita, b' “C2” immarkata fuq naħa waħda.
English: • anticonvulsant medicines used to treat fits (seizures) and epilepsy - such as phenytoin
Maltese: • mediċini kontra l-aċċessjonijiet, li jintużaw biex jittrattaw l-aċċessjonijiet (puplesiji) u epilessija - bħal phenytoin
English: No effects on male and female fertility were observed in 3-month general toxicology studies in rats and dogs at exposures of 0.09 to 0.3 times the human AUC at the recommended dose.
Maltese: Ma ġie osservat l-ebda effett fuq il-fertilità tal-irġiel u tan-nisa fi studji ġenerali tossikoloġiċi li damu 3 xhur fil-firien u fil-klieb f'esponimenti ta' 0.09 sa 0.3 darbiet tal-AUC uman fid-doża rakkomandata.
English: • medicines to treat migraines and headaches - such as dihydroergotamine or ergotamine
Maltese: • mediċini biex jittrattaw emigranji u wġigħ ta' ras - bħal dihydroergotamine jew ergotamine
English: In vitro, rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Maltese: In vitro, rucaparib hu inibitur potenti ta' MATE1 u MATE2-K, inibitur moderat ta' OCT1, u inibitur dgħajjef ta' OCT2.
English: Thrombocytopenia and anaemia led to discontinuation in 1.8% and 2.1% of patients.
Maltese: It-tromboċitopenija u lanemija wasslu għat-twaqqif f'1.8% u 2.1% tal-pazjenti.
English: HR (95% CI) p-valueb nonBRCA LOH+ Group
Maltese: Grupp mhux BRCA LOH+
English: Intravenous administration of rucaparib in the rat and dog induced cardiac effects at a high Cmax (5.4 to 7.3-fold higher than patients), but not at a lower Cmax (1.3 to 3.8-fold higher than patients).
Maltese: L-għoti fil-vini tar-rucaparib fil-firien u l-klieb ikkawżaw effetti kardijaki b' Cmax għoli (5.4 sal 7.3 darbiet ogħla milli pazjenti), iżda mhux Cmax iktar baxx (1.3 sa 3.8 darbiet ogħla minn pazjenti).
English: • Rubraca 250 mg film-coated tablets are white, diamond-shaped, film-coated tablets with “C25” marked on one side.
Maltese: • Rubraca 250 mg pilloli miksija b'rita huma bojod, b'forma ta' djamant, pilloli miksija b'rita, b' “C25” immarkata fuq naħa waħda.
English: Median duration of responsea - days (95% CI)
Maltese: Rispons parzjali % Medjan tat-tul tar-risponsa - jiem (95% CI)
English: Abdominal pain (combined terms abdominal pain, abdominal pain lower, abdominal pain upper) was reported in 40.1% of rucaparib treated patients, but was also very common (33%) in placebo patients, most likely associated with underlying disease.
Maltese: Uġigħ addominali (termini kombinati uġigħ addominal, uġigħ addominali fil-parti t'isfel, uġigħ addominali fil-parti ta' fuq) ġie rrappurtat f'40.1 % tal-pazjenti ttrattati b'rucaparib, iżda kien ukoll komuni ħafna (33 %) f'pazjenti tal-plaċebo, li aktarx kien assoċjat ma' marda sottostanti.
English: Tumour tissue samples for all of the patients (N=564) were tested centrally to determine HRD positive status (as defined by the presence of a deleterious tumour BRCA [tBRCA] mutation or high genomic loss of heterozygosity).
Maltese: Il-kampjuni tat-tessut tat-tumur għall-pazjenti kollha (N=564) ġew ittestjati ċentralment sabiex jiġi ddeterminat status pożittiv għal HRD (kif definita mill-preżenza ta' mutazzjoni ta' BRCA tat-tumur
English: Based on in vitro data, CYP2D6, and to a lesser extent CYP1A2 and CYP3A4, were able to metabolize rucaparib.
Maltese: Ibbażat fuq data in vitro, CYP2D6, u fi grad inqas CYP1A2 u CYP3A4, kienu kapaċi jimmetabolizzaw rucaparib.
English: Rubraca 250 mg film-coated tablets rucaparib
Maltese: Rubraca 250 mg pilloli miksija b'rita rucaparib
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Maltese: malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: Adverse reactions may be managed through dose interruptions and/or dose reductions for moderate to severe reactions (i.e. CTCAE Grade 3 or 4) such as neutropenia, anaemia and thrombocytopenia.
Maltese: Ir-reazzjonijiet avversi jistgħu jiġu mmaniġġjati permezz ta' interruzzjonijiet tad-doża u/jew it-tnaqqis fid-doża għal reazzjonijiet moderati sa severi (i.e. CTCAE Grad 3 jew 4) bħal newtropenija, anemija u tromboċitopenija.
English: Although in vitro rucaparib metabolism mediated by CYP3A4 was slow, a significant contribution of CYP3A4 in vivo cannot be excluded.
Maltese: Għalkemm il-metaboliżmu tar-rucaparib in vitro mmedjat permezz ta' CYP3A4 kien miexi bil-mod, ma tistax tiġi eskluża kontribuzzjoni sinifikanti ta' CYP3A4 in vivo.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX55
Maltese: Sustanzi antineoplastiċi oħrajn, Kodiċi ATC:
English: This means you take a total of 1,200 mg each day.
Maltese: Dan ifisser li inti se tieħu total ta' 1,200 mg kuljum.
English: Myelodysplastic syndrome / Acute myeloid leukaemia
Maltese: Sindrome majelodisplastiku/Lewkimja majelojde akuta
English: Leukopeniab, Lymphopeniab, Febrile neutropenia
Maltese: Tnaqqis fl-aptit, Żieda talkreatinina fid-demmb
English: Gastrointestinal toxicities (nausea and vomiting) are frequently reported with rucaparib, are generally low grade (CTCAE Grade 1 or 2), and may be managed with dose reduction (refer to Table 1) or interruption.
Maltese: Tossiċitajiet gastrointestinali (dardir u rimettar) huma rrappurtati ta' spiss b'rucaparib, huma ġeneralment ta' grad baxx (CTCAE Grad 1 jew 2), u jistgħu jiġu mmaniġġjati bi tnaqqis fid-doża (ara Tabella 1) jew l-interruzzjoni tad-doża.
English: • feeling dizzy
Maltese: • tħossok imdardar
English: Blue, 11 mm, round film-coated tablet, debossed with “C2”.
Maltese: Pillola miksija b'rita tonda u blu, 11 mm, imnaqqxa b' “C2”.
English: Tablet coating Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 (E1521)
Maltese: Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc
English: Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain
Maltese: Dardir, Rimettar, Dijarea, Uġigħ addominali
English: Take care in direct sunlight
Maltese: Oqgħod attenta f'xemx diretta
English: b Includes laboratory findings c Includes fatigue, asthenia and lethargy
Maltese: b Tinkludi r-riżultati tal-laboratorju c Tinkludi għeja, astenija u letarġija
English: Rubraca 300 mg film-coated tablets rucaparib
Maltese: Rubraca 300 mg pilloli miksija b'rita rucaparib
English: In an animal reproduction study, administration of rucaparib to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see section 5.3).
Maltese: Fi studju tar-riproduzzjoni tal-annimali, l-għoti ta' rucaparib lil firien tqal matul il-perjodu tal-organiġenesi wassal għal tossiċità embrijufetali f'espożizzjonijiet inferjuri għal dawk f'pazjenti li jirċievu d-doża umana rakkomandata ta' 600 mg darbtejn kuljum (ara sezzjoni 5.3).
English: The overall safety profile of rucaparib is based on data from 937 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy.
Maltese: Il-profil tas-sigurtà globali ta' rucaparib huwa bbażat fuq data minn 937 pazjent fil-provi kliniċi f'kanċer tal-ovarji ttrattati b'monoterapija b'rucaparib Reazzjonijiet avversi li seħħew f'≥ 20% tal-pazjenti li kienu qed jirċievu rucaparib kienu dardir,
English: - Rubraca 300 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), and iron oxide yellow (E172).
Maltese: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 (E151) Talc (E553b) Iron oxide yellow (E172)
English: Median overall survival - months (95% CI)
Maltese: Medjan ta' sopravivenza globali - xhur (95% CI)
English: • feeling sick (nausea)
Maltese: • tħossok sturdut
English: Rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Maltese: Rucaparib hu inibitur potenti ta' MATE1 u MATE2-K, inibitur moderat ta' OCT1, u inibitur dgħajjef ta' OCT2.
English: No studies have been conducted to investigate the pharmacokinetics of rucaparib in paediatric patients.
Maltese: Ma sar ebda studju biex jinvestiga l-farmakokinteika ta' rucaparib f'pazjenti pedjatriċi.
English: • Rubraca 300 mg film-coated tablets are yellow, oval, film-coated tablets with “C3” marked on one side.
Maltese: • Rubraca 300 mg pilloli miksija b'rita huma sofor, ovali, pilloli miksija b'rita, b' “C3” immarkata fuq naħa waħda.
English: Because of the potential for serious adverse reactions in breast-fed infants from rucaparib, breast-feeding is contraindicated during treatment with Rubraca and for 2 weeks after the final dose (see section 4.3).
Maltese: Minħabba l-potenzjal għal reazzjonijiet avversi serji minn rucaparib fi trabi mredda', it-treddigħ huwa kontraindikat matul it-trattament b'Rubraca u għal ġimagħtejn wara d-doża finali (ara sezzjoni 4.3).
English: In vitro, M324 was at least 30 fold less potent than rucaparib against PARP-1, PARP-2, and PARP-3.
Maltese: In vitro, M324 kien tal-inqas 30 darba inqas qawwi minn rucaparib kontra PARP-1, PARP-2, u PARP-3. Metaboliti minuri oħra ammontaw għal 13.8 % tar-radjuattività fil-plażma.
English: The efficacy of rucaparib was investigated in ARIEL3, a double-blind, multicentre clinical trial in which 564 patients with recurrent EOC, FTC or PPC who were in response to platinum-based chemotherapy were randomized (2:1) to receive Rubraca tablets 600 mg orally twice daily (n=375) or placebo (n=189).
Maltese: Kura ta' manteniment ta' kanċer tal-ovarji rikorrenti L-effikaċja ta' rucaparib ġiet investigata f'ARIEL3, prova klinika double-blind, multiċentrika li fiha 564 pazjent b'EOC, FTC jew PPC rikorrenti li kienu f'rispons għal kimoterapija bbażata fuq ilplatinum ġew randomizzati (2:1) biex jirċievu Rubraca pilloli 600 mg mill-ħalq darbtejn kuljum
English: Fatiguec
Maltese: Effikaċja
English: Interrupt rucaparib until values return to Grade ≤ 2; then resume rucaparib with a dose reduction and monitor LFTs weekly for 3 weeks
Maltese: Interrompi rucaparib sakemm il-valuri jirritornaw għal Grad ≤ 2; imbagħad kompli rucaparib bi tnaqqis fid-doża u mmonitorja l
English: In addition, rucaparib is an inhibitor of the BCRP with IC50 value suggesting potential BCRP inhibition and increased exposures of medicinal products that are BCRP substrates (e.g., rosuvastatin).
Maltese: Barra minn hekk, rucaparib hu inibitur tal-BCRP b'valur ta' IC50 li jissuġġerixxi inibizzjoni potenzjali ta' BCRP u żieda flesponimenti ta' prodotti mediċinali li huma substrati ta' BCRP (eż., rosuvastatin).
English: Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube,
Maltese: Sabiex tikkonferma ulterjorment is-sigurtà u l-effikaċja ta' rucaparib fit trattament ta' kanċer sensittiv għall-platinum, li jirkadi jew progressiv f'pazjenti adulti b'mutazzjoni ta' BRCA (germline BRCA u/jew mutazzjonijiet somatiċi),
English: b. Two-sided p-value c. HRD includes all patients with a deleterious germline or somatic BRCA mutation or non-tBRCA with high genomic loss of heterozygosity, as determined by the clinical trial assay (CTA).
Maltese: HRD tinkludi l-pazjenti kollha b'mutazzjoni BRCA fil-linja ġerminali deleterjuża jew somatika jew mhux tBRCA b'telf ġenomiku għoli ta' eterożigożità, kif iddeterminat mill assaġġ tal-prova klinika (CTA).
English: Each tablet contains rucaparib camsylate corresponding to 250 mg rucaparib.
Maltese: Kull pillola fiha rucaparib camsylate li jikkorrispondi għal 250 mg ta' rucaparib.
English: There are limited clinical data in patients with moderate or severe hepatic impairment (ie, any total bilirubin greater than 1.5 times ULN), therefore rucaparib is not recommended for use in patients with moderate or severe hepatic impairment.
Maltese: Hemm data klinika limitata f'pazjenti b'indeboliment moderat jew sever tal-fwied (jiġifieri, kwalunkwe bilirubina totali akbar minn 1.5 darbiet l-ULN), u għalhekk rucaparib mhuwiex rakkomandat għall-użu f'pazjenti b'indeboliment moderat jew sever tal-fwied.
English: Pyrexia a MDS/AML rate is based on overall total patient population of 1321 who have received one dose of oral rucaparib.
Maltese: Deni a Ir-rata ta' MDS/AML hi bbażata fuq il-popolazzjoni tal-pazjent ġenerali totali ta' 1321 li rċivew doża waħda ta' rucaparib orali.
English: Prior bevacizumab therapy was reported for 22% of patients who received rucaparib and 23% of patients who received placebo.
Maltese: Terapija b'bevacizumab preċedenti ġiet irrappurtata għal 22 % tal-pazjenti li rċivew rucaparib u 23 % talpazejnti li rċivew il-plaċebo.
English: Rubraca 200 mg film-coated tablets rucaparib
Maltese: Rubraca 200 mg pilloli miksija b'rita rucaparib
English: Patients could not have received prior rucaparib or other PARP inhibitor therapy.
Maltese: Il pazjenti ma setgħux jirċievu rucaparib jew terapija preċedenti oħra b'inibitur PARP.
English: Fatiguec, Pyrexia
Maltese: FULJETT TA' TAGHRIF
English: - Rubraca 250 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), and talc (E553b)
Maltese: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 (E1521) Talc (E553b)
English: Increased rucaparib-induced cytotoxicity and anti-tumour activity was observed in tumour cell lines with deficiencies in BRCA1/2 and other DNA repair genes.
Maltese: Ġiet osservata żieda fiċ-ċitotossiċità indotta minn rucaparib u fl-attività kontra t-tumur f'linji ta' ċelluli tat-tumur b'defiċjenza f'BRCA1/2 u f'ġeni oħra ta' tiswija tad-DNA.
English: • heartburn
Maltese: Plaċebo
English: You may need medical help.
Maltese: Jista' jkollok bżonn ta' trattament mediku.
English: A total of 32% of patients were in complete response (CR) to their most recent therapy.
Maltese: Total ta' 32 % tal-pazjenti kienu f'rispons sħiħ (CR) għall-aktar terapija riċenti tagħhom.
English: Children unde 18 years of age should not be given Rubraca, This medicine has not beem studied in this age group.
Maltese: Din il-mediċina ma ġietx studjata f'dan il-grupp ta' età.
English: Before taking Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC, patients must have confirmation of deleterious germline or somatic mutations in the breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene using a validated test.
Maltese: Qabel ma jieħdu Rubraca bħala trattament għal EOC, FTC, jew PPC rikadut jew progressiv, il-pazjenti jrid ikollhom konferma ta' mutazzjoni ta' ħsara germline jew mutazzjonijiet somatiċi fil-ġene talkanċer tas-sider 1 (BRCA1) jew kanċer tas-sider 2 (BRCA2) bl-użu ta' test validat.
English: Dysgeusia, Dizziness
Maltese: Dispepsija, Uġigħ addominali
English: In repeat-dose toxicity studies of up to 3 months duration in rats and dogs, the target organs were the gastrointestinal, haematopoietic, and lymphopoietic systems.
Maltese: Fi studji dwar tossiċità minn dożi ripetuti li damu sa 3 xhur fil-firien u l-klieb, l-organi fil-mira kienu s-sistemi gastrointestinali,
English: Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinumsensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Maltese: Rubraca huwa indikat bħala monoterapija għat-trattament ta' manteniment ta' pazjenti adulti b'kanċer tal-ovarji epiteljali, tat-tubi fallopjani, jew kanċer primarju tal-peritonew ta' grad għoli, rikadut, sensittiv għall-platinu li jkunu f'rispons (sħiħ jew parzjali) għal kimoterapija bbażata fuq il-platinum.
English: Randomisation was stratified by best response to last platinum therapy (complete or partial), time to progression following the penultimate platinum therapy (6 to ≤ 12 months and > 12
Maltese: Irrandomizzazzjoni ġiet stratifikata mill-aħjar rispons għall-aħħar terapija bil-platinum (sħiħ jew parzjali), żmien għall-progressjoni wara t-terapija ta' qabel tal-aħħar bil-platinum, (6 sa ≤ 12-il xahar u
English: Median progression-free survival - days (95% CI)
Maltese: Medjan ta' sopravivenza mingħajr progressjoni f'jiem (95% CI)