FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be used when rucaparib is co-administered with UGT1A1 substrates (i.e. irinotecan) to patients with UGT1A1*28 (poor metabolizer) due to a possible increase in the exposure of SN-38 (the active metabolite of irinotecan) and associated toxicities.
Maltese: Għandha tingħata attenzjoni meta rucaparib jingħata flimkien ma' substrati UGT1A1 (i.e. irinotecan) lil pazjenti b'UGT1A1*28 (metabolizzatur dgħajjef) minħabba żieda potenzjali fl-espożizzjoni ta' SN-38 (il-metabolit attiv ta' irinotecan) u tossiċitajiet assoċjati.
English: Rucaparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair.
Maltese: Rucaparib hu inibitur tal-enzimi poly(ADP-ribose) polymerase (PARP), li jinkludu PARP-1, PARP-2, u PARP-3, li għandhom rwol fit-tiswija tad-DNA.
English: Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome, Erythema
Maltese: Raxx makulo-papulari, Sindrome ta' eritrodisestesija palmar-plantar, Eritema
English: Tabulated list of adverse reactions by MedDRA system organ class Adverse reactions
Maltese: Tabella 3. Lista tabulata tar-reazzjonijiet avversi skont is-sistema tal-klassifika tal-organi
English: Most of the primary efficacy population were platinum-sensitive (n=79, 74.5%); the remaining patients were platinum-resistant (n=20, 18.9%) or platinum-refractory (n=7, 6.6%).
Maltese: Ħafna mill-popolazzjoni tal-effikaċja primarja sensittivi għall-platinum (n=79, 74.5%); u l-bqija talpazjenti kienu reżistenti għall-platinum (n=20, 18.9%) jew refrattarji għall-platinum (n=7, 6.6%).
English: The absolute oral bioavailability at 600 mg has not been determined.
Maltese: Il-bijodisponibiltà orali assoluta f'doża ta' 600 mg ma ġietx stabbilita.
English: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib.
Maltese: Sindrome majelodisplastiku/lewkimja majelojde akuta (MDS/AML, Myelodysplastic syndrome/Acute myeloid leukaemia), inkluż każijiet b'riżultat fatali, ġew irrappurtati f'pazjenti li rċivew rucaparib.
English: Nervous system disorders Very common
Maltese: Disturbi fis-sistema nervuża
English: Renal impairment
Maltese: Intervall ta' kunfidenza
English: The median progression-free survival was 162 days (95% CI [51-223]).
Maltese: Is-sopravivenza medjana mingħajr progressjoni kienet 162 jum (95% CI [51-223]).
English: Rucaparib is a weak inhibitor of CYP2C8, CYP2D6, and UGT1A1.
Maltese: Rucaparib hu inibitur dgħajjef ta' CYP2C8, CYP2D6, u UGT1A1.
English: ARIEL3 Efficacy Results Parameter
Maltese: ARIEL3 Riżultati tal-Effikaċja
English: • Talk to your doctor or pharmacist about the most effective methods of contraception.
Maltese: • Kellem lit-tabib jew lill-ispiżjar tiegħek dwar l-aktar metodi effettivi ta' kontraċezzjoni.
English: Rucaparib increased S-warfarin Cmax by 1.05 fold (90% CI: 0.99 to 1.12) and AUC0-96h by 1.49 fold (90% CI: 1.40 to 1.58), respectively.
Maltese: Rucaparib żied is-Cmax ta' S-warfarin b'1.05 darbiet (90% CI: 0.99 sa 1.12) u l-AUC0-96h b'1.49 darbiet (90% CI: 1.40 sa 1.58), rispettivament.
English: Rucaparib induced CYP1A2, and down regulated CYP2B6 and CYP3A4 in human hepatocytes at clinically relevant exposures.
Maltese: Rucaparib induċa lil CYP1A2 u rregola ‘l isfel CYP2B6 u CYP3A4 fl-epatoċiti umani f'esponimenti klinikament rilevanti.
English: Rubraca is an anti-cancer medicine, also known as a ‘PARP (poly adenosine diphosphate-ribose polymerase) inhibitor'.
Maltese: Rubraca hija mediċina kontra l-kanċer, magħrufa wkoll bħala ‘inibitur ta' PARP (poly adenosine diphosphate-ribose polymerase)'.
English: In vitro, rucaparib was shown to be a substrate of P-gp and BCRP.
Maltese: In vitro, rucaparib intwera li kien substrat ta' P-gp u BCRP.
English: The mean age was 61 years (range: 36 to 85); most of the patients were white (80%); and all had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Maltese: L-età medja kienet 61 sena (medda: 36 sa 85); ħafna mill-pazjenti kienu bojod (80%); u kollha kellhom stat tal-prestazzjoni tal-Eastern Cooperative Oncology Group (ECOG) ta' 0 jew 1.
English: In an exploratory analysis, a response was noted in 38% (95% CI 23% - 54%) of patients (n=15) on rucaparib compared to 9% (95% CI 1%28%) of patients (n=2) on placebo (2-sided p-value = 0.0055), including 7 (18%) patients in the rucaparib group who achieved a complete remission.
Maltese: F'analiżi esploratorja, ġie nnutat rispons fi 38 % (95% CI 23% - 54%) tal-pazejnti (n=15) fuq rucaparib meta mqabbel ma' 9 % % (95% CI 1% - 28%) tal-pazjenti (n=2) fuq il-plaċebo (valuru p miż-żewġ naħat = 0.0055), inkluż 7
English: Other medicines and Rubraca
Maltese: Mediċini oħra u Rubraca
English: Grade ≥ 3 LFT abnormalities.
Maltese: grad 3 u ogħla
English: Blood samples for 94% (186/196) of the tBRCA patients were evaluated using a central blood germline BRCA (gBRCA) test. Based on these results, 70% (130/186) of the tBRCA patients had a gBRCA mutation and 30% (56/186) had a somatic BRCA mutation.
Maltese: Abbażi ta' dawn ir-riżultati, 70 % (130/186) tal-pazjenti tBRCA kellhom mutazzjoni gBRCA u 30 % (56/186) kellhom mutazzjoni BRCA somatika.
English: 400 mg twice daily (two 200 mg tablets twice daily)
Maltese: 400 mg darbtejn kuljum (żewġ pilloli ta' 200 mg darbtejn kuljum)
English: Data suggest that rucaparib is a moderate inhibitor of CYP1A2, and a mild inhibitor of CYP2C9, CYP2C19, and CYP3A.
Maltese: Id-data tissuġġerixxi li rucaparib hu inibitur moderat ta' CYP1A2, u inibitur ħafif ta' CYP2C9, CYP2C19, u CYP3A.
English: Platinum Sensitive N=79
Maltese: N=79
English: The findings in non-clinical toxicology studies performed with oral rucaparib were generally consistent with the adverse events observed in clinical studies.
Maltese: Ir-riżultati fl-istudji tossikoloġiċi mhux kliniċi mwettqa b'rucaparib orali kienu ġeneralment konsistenti mal-avvenimenti avversi osservati fl-istudji kliniċi.
English: Complete response % Partial response %
Maltese: Rispons sħiħ %
English: • Tablet coating: - Rubraca 200 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133) and indigo carmine aluminium lake (E132).
Maltese: Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133) u indigo carmine aluminium lake
English: Patients with mild renal impairment (N=149; CLcr between 60 and 89 mL/min, as estimated by the Cockcroft-Gault method) and those with moderate renal impairment (N=76; CLcr between 30 and 59 mL/min) showed approximately 15% and 33% higher steady-state AUC, respectively, compared to patients with normal renal function (N=147; CLcr greater than or equal to 90 mL/min).
Maltese: Pazjenti b'indeboliment ħafif tal-kliewi (N=149; CLcr bejn 60 u 89 mL/min, kif stmat bil-metodu Cockcroft-Gault) u dawk b'indeboliment moderat talkliewi (N=76; CLcr bejn 30 u 59 mL/min), urew bejn wieħed u ieħor AUC ogħla b'15% u 33% fl-istat fiss, rispettivament, meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi (N=147; CLcr akbar minn jew ugwali għal 90 mL/min).
English: Rucaparib increased omeprazole Cmax by 1.09 fold (90% CI: 0.93 to 1.27) and AUCinf by 1.55 fold (90% CI: 1.32 to 1.83).
Maltese: Rucaparib żied is-Cmax ta' omeprazole b'1.09 darbiet (90% CI: 0.93 sa 1.27) u l-AUCinf b'1.55 darbiet (90% CI: 1.32 sa 1.83).
English: The risk for a clinically relevant effect of concomitant administration of proton pump inhibitors (PPIs) is likely small (see section 5.2).
Maltese: Ir-riskju għal effett klinikament rilevanti ta' għoti fl-istess ħin ta' inibituri talpompa tal-protoni (proton pump inhibitors - PPIs) huwa żgħir probabbilment (ara sezzjoni 5.2).
English: Anaemiab
Maltese: Anemijab
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 persuna minn kull 100):
English: Rubraca 200 mg film-coated tablets Rubraca 250 mg film-coated tablets Rubraca 300 mg film-coated tablets
Maltese: Rubraca 200 mg pilloli miksija b'rita Rubraca 250 mg pilloli miksija b'rita Rubraca 300 mg pilloli miksija b'rita
English: Increased ALT was observed in 34.8% (all grades) and 9.9% (≥ CTCAE Grade 3) of patients, increased AST in 31.4% (all grades) and 2.8% (≥ CTCAE Grade 3) of patients and increased ALT and AST in 28.6% (all grades) and 2.1% (≥ CTCAE Grade 3) of patients.
Maltese: Żieda fl-ALT kienet osservata f'34.8 % (il-gradi kollha) u 9.9 % (≥ CTCAE Grad 3) tal-pazjenti, żieda fl-AST f'31.4 % (il-gradi kollha) u 2.8 % (≥ CTCAE Grad 3) tal-pazjenti u żieda fl-ALT u fl-AST fi 28.6 % (il-gradi kollha) u 2.1 % (≥ CTCAE Grad 3) talpazjenti.
English: In vitro, the IC50 of rucaparib against the human ether-à-go-go related gene (hERG) was 22.6 µM, which is approximately 13-fold higher than the Cmax in patients at the recommended dose.
Maltese: In vitro, l-IC50 tar-rucaparib kontra l-ġenu ether-à-go-go (hERG) kien 22.6 µM, li huwa madwar 13-il-darba ogħla mis- Cmax f'pazjenti bid-doża rakkomandata.
English: Medicinal product interactions
Maltese: Interazzjonijiet ma' prodotti mediċinali
English: Concentration-QTcF prolongation analysis was conducted using data from 54 patients with a solid tumour administered continuous rucaparib at doses ranging from 40 mg once daily to 840 mg twice daily (1.4 times the approved recommended dose).
Maltese: L-analiżi tal-prolongazzjoni tal-konċentrazzjoni-QTcF saret bl-użu ta' data minn 54 pazjent b'tumur solidu li ngħataw dożi kontinwi ta' rucaparib li varjaw minn 40 mg darba kuljum għal 840 mg darbtejn kuljum (1.4 darbiet tad-doża rakkomandata approvata).
English: At the predicted median steady-state Cmax following 600 mg rucaparib twice daily, the projected QTcF increase from baseline was 11.5 msec (90% CI: 8.77 to 14.2 msec).
Maltese: F' Cmax fi stat fiss medju pprevedut wara 600 mg rucaparib darbtejn kuljum, iż-żieda proġettata tal-QTcF mil-linja bażi kienet ta'11.5 msek CI: 8.77 sa 14,2 msek.
English: Rucaparib increased midazolam Cmax by 1.13 fold (90% CI: 0.95 to 1.36) and AUCinf by 1.38 fold (90% CI: 1.13 to 1.69).
Maltese: Rucaparib żied is-Cmax ta' midazolam b'1.13 darbiet (90% CI: 0.95 sa 1.36) u l-AUCinf b'1.38 darbiet (90% CI: 1.13 sa 1.69).
English: Study 10 population characteristics in 42 patients were: median age 57 years (range 42 to 84), white (83%), ECOG performance status 0 (62%) or 1 (38%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (36%), median time since ovarian cancer diagnosis 43 months [range: 6178], median progression-free interval from the last platinum treatment 8.0 months [range: 6.0
Maltese: Il-karatteristiċi tal-popolazzjoni fi Studju 10 fi 42 pazjent kienu: medjan ta' età ta' 57 sena (medda 42 sa 84), bojod (83%), stat ta' prestazzjoni ECOG 0 (62%) jew 1 (38%), kanċer tal-ovarji ta' grad għoli (100%), 3 jew aktar korsijiet ta' kimoterapija fil-passat (36%), żmien medjan mid-dijanjosi ta' kanċer tal-ovarji (43 xahar [medda: 6 - 178]), intervall medjan mingħajr progressjoni mill-aħħar trattament bil-platinum (8.0 xhur [medda: 6.0 - 116.4]).
English: Patients included in the population PK study were aged 21 to 86 years (58% < 65 years, 31% 65-74 years, and 11% > 75 years), 82% were Caucasian, and had body weights between 41 and 171 kg (73% had body weight > 60 kg).
Maltese: Ilpazjenti inklużi fl-istudju dwar il-PK tal-popolazzjoni kellhom minn 21 sa 86 sena (58% kellhom <65 sena, 31% kellhom 65-74 sena, u 11% kellhom > 75 sena), 82% kienu Kawkasi, u kellhom piżijiet talġisem bejn 41 u 171 kg (73% kellhom piż tal-ġisem ta' > 60 kg).
English: Photosensitivity reaction, Rash, Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome
Maltese: Raxx makulopapulari, Sindrome ta' eritrodisestesija palmar-plantar
English: During treatment with rucaparib, events of myelosuppression (anaemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8-10 weeks of treatment with rucaparib.
Maltese: Matul it-trattament b'rucaparib, avvenimenti ta' majelosoppressjoni (anemija, newtropenija, tromboċitopenija) jistgħu jiġu osservati u tipikament jiġu osservati l-ewwel wara 8-10 ġimgħat ta' trattament b'rucaparib.
English: Vomiting and nausea were reported in 42% and 77% of patients, respectively and were generally low grade (CTCAE Grade 1 to 3).
Maltese: Rimettar u dardir ġew irrappurtati fi 42% u f'77% tal-pazjenti, rispettivament u ġeneralment kienu ta' grad baxx (CTCAE Grad 1 sa 3).
English: In the ITT population, 38% of patients (141/375) in the rucaparib group and 35% of patients (66/189) in the placebo group had measurable disease at baseline.
Maltese: Fil-popolazzjoni ITT, 38 % tal-pazjenti (141/375) fil-grupp ta' rucaparib u 35 % tal-pazjenti (66/189)
English: In patients with cancer following rucaparib 600 mg taken twice daily, the mean steady-state Cmax was 1940 ng/mL and AUC0-12h was 16900 h⋅ng/mL with Tmax of 1.9 hours.
Maltese: F'pazjenti bil-kanċer wara li ħadu rucaparib 600 mg darbtejn kuljum, il-medja tas-Cmax kienet 1940 ng/mL u l-AUC0-12h kien 16900 h⋅ng/mL b'Tmax ta' 1.9 sigħat.
English: For the platinum-refractory population (N=7), there were no responders.
Maltese: Għall-popolazzjoni refrattarja għall-platinum (N=7), ma kien hemm ħadd li ta rispons.
English: In patients ≥ 75 years old, frequencies of some adverse reactions increased: increased blood creatinine (32%), dizziness (20%), pruritus (15%), and memory impairment (4%) were higher than in patients < 75 years old (18%, 15%, 9% and 1% respectively).
Maltese: F'pazjenti li kellhom ≥ 75 sena, żdiedu l-frekwenzi ta' xi reazzjonijiet avversi: żieda fil-kreatinina fiddemm (32%), sturdament (20%), ħakk (15%), u indeboliment tal-memorja (4%) kienu ogħla milli f'pazjenti li kellhom < 75 sena (18%, 15%, 9% u 11% rispettivament).
English: Rucaparib showed no effect on Cmax of caffeine while moderately increasing AUCinf of caffeine by 2.55 fold (90% CI: 2.12, 3.08).
Maltese: Rucaparib ma wera l-ebda effett fuq is-Cmax tal-kaffeina, filwaqt li żied moderatament l-AUCinf talkaffeina bi 2.55 darbiet (90% CI: 2.12, 3.08).
English: In the pivotal Phase 3 study (ARIEL3), the incidence of MDS/AML during therapy in patients who received rucaparib was 0.8%.
Maltese: Fl-istudju pivotali ta' Fażi 3 (ARIEL3), l-inċidenza ta' MDS/AML matul it-terapija f'pazjenti li rċivew rucaparib kienet 0.8%.
English: In the subset of 79 platinum-sensitive patients, progression free interval after last platinum dose was ≥ 6 - 12 months for 55 (69.6%) patients and > 12 months for 24 (30.4%) patients.
Maltese: Fis-sottosett ta' 79 pazjent sensittivi għall-platinum, l-intervall mingħajr progressjoni kien ta' ≥ 6 - 12-il xahar għal 55 (69.6%) pazjent, u ta' > 12-il xahar għal 24 (30.4%) pazjent.
English: In the tBRCA population, 31% of patients (40/130) in the rucaparib group and 35% of patients (23/66) in the placebo group had measurable disease at baseline.
Maltese: Fil-popolazzjoni tBRCA, 31 % tal-pazjenti (40/130) fil-grupp ta' rucaparib u 35 % tal-pazjenti (23/66)
English: Thrombocytopeniab, Neutropeniab, Febrile neutropenia, Leukopeniab
Maltese: Tromboċitopenijab, Newtropenijab, Newtropenija bid-deni, Lewkopenijab
English: Gastrointestinal disorders Very common
Maltese: Disturbi gastrointestinali
English: The in vitro protein binding of rucaparib is 70.2% in human plasma at therapeutic concentration levels.
Maltese: It-twaħħil in vitro mal-proteini ta' rucaparib hu 70.2% fil-plażma umana f'livelli ta' konċentrazzjoni terapewtiċi.
English: White, 11 x 15 mm, diamond-shaped film-coated tablet, debossed with “C25”.
Maltese: Pillola miksija b'rita b'forma ta' djamant u bajda, 11 x 15 mm, imnaqqxa b' “C25”.
English: Myelodysplastic syndrome/Acute myeloid leukaemia MDS/AML are serious adverse reactions that occur uncommonly (0.5%) in patients on treatment and during the 28 day safety follow up, and commonly (1.3%) for all patients including during the long term safety follow up (rate is calculated based on overall safety population of 1321 patients exposed to at least one dose of oral rucaparib in all clinical studies).
Maltese: MDS/AML huma reazzjonijiet avversi serji li jseħħu b'mod mhux komuni (0.5%) f'pazjenti fuq ittrattament u matul il-perjodu ta' follow-up ta' 28 jum, u b'mod komuni (1.3%) għall-pazjenti kollha matul il-perjodu ta' follow-up fit-tul tas-sigurtà (ir-rata hi kkalkulata skont il-popolazzjoni totali tassigurtà ta' 1321 pazjent esposti għal mill-inqas doża waħda ta' rucaparib orali fl-istudji kliniċi kollha).
English: Treatment of BRCA-mutated ovarian cancer after 2 or more chemotherapies The efficacy of rucaparib was investigated in 106 patients in 2 multicentre, single-arm, open-label clinical studies, Study 10 and ARIEL2, in patients with advanced BRCA-mutant epithelial ovarian, fallopian tube or primary peritoneal cancer who had progressed after 2 or more prior chemotherapies (the primary efficacy population).
Maltese: Kura ta' kanċer tal-ovarji b'mutazzjoni ta' BRCA wara 2 kimoterapiji jew aktar L-effikaċja ta' rucaparib ġiet investigata f'106 pazjent f'2 studji kliniċi, multiċentriċi, b'parti waħda, open label, Studju 10 u ARIEL2, f'pazjenti b'kanċer tal-ovarji epiteljali avvanzat b'mutazzjonijiet BRCA, kanċer tat-tubu fallopjan jew peritoneali primarju li l-marda tagħhom aggravat wara 2 korsijiet ta' kimoterapija jew aktar fil-passat (il-popolazzjoni tal-effikaċja primarja).
English: • abnormal blood tests - increase in levels of liver enzymes
Maltese: • testijiet tad-demm anormali - żieda fil-livelli ta' enzimi tal-fwied
English: Rucaparib down regulated CYP2B6 in human hepatocytes at clinically relevant exposures.
Maltese: Rucaparib irreogla ‘l isfel CYP2B6 fl-epatoċiti umani f'esponimenti klinikament rilevanti.
English: Dysgeusia, Dizziness,
Maltese: midazolam, u digoxin, rispettivament).
English: In vitro, rucaparib is metabolised primarily by CYP2D6, and to a lesser extent by CYP1A2, and CYP3A4.
Maltese: In vitro, rucaparib jiġi metabolizzat primarjament minn CYP2D6, u fi grad inqas minn CYP1A2, u CYP3A4.
English: 282 days (95% CI [218-335]), and the median overall survival was 18.8 months (95% CI [12.9-NA]).
Maltese: Is-sopravivenza medjana mingħajr progressjoni kienet 282 jum (95% CI [218-335]), u s-sopravivenza medjana globali kienet 18.8 xhur (95% Cl [12.9-NA]).
English: Lymphopeniab
Maltese: Newtropenijab
English: Limited data are available for patients with moderate or severe hepatic impairment (see section 4.2).
Maltese: Dejta limitata hi disponibbli għal pazjenti b'indeboliment moderat jew sever tal-fwied (ara sezzjoni 4.2).
English: The clinical relevance MRP2 and MRP3 interaction in the gut is not known.
Maltese: Ir-rilevanza klinika ta' interazzjoni ma' MRP2 u MRP3 fl-imsaren mhijiex magħrufa.
English: Plasma exposures of rucaparib, as measured by Cmax and AUC, were approximately dose proportional at evaluated doses (40 to 500 mg daily, 240 to 840 mg twice a day).
Maltese: L-esponimenti ta' rucaparib fil-plażma, kif imkejla mis-Cmax u l-AUC, kienu bejn wieħed u ieħor proporzjonali għad-doża f'dożi evalwati (40 sa 500 mg kuljum, 240-840 mg darbtejn kuljum).
English: ITT populationa
Maltese: TA' EĊĊIPJENTI
English: No clinically important differences were observed between 34 patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin > 1.0 to 1.5 times ULN and any AST) and 337 patients with normal hepatic function.
Maltese: Ma ġew osservati l-ebda differenzi klinikament importanti bejn 34 pazjent b'indeboliment ħafif tal-fwied (bilirubina totali ≤ ULN u AST > ULN jew bilirubina totali ta' > 1.0 sa 1.5 darbiet tal-ULN u kwalunkwe AST) u 337 pazjent b'funzjoni normali tal-fwied.
English: Following administration of a single oral dose of [14C]-rucaparib 600 mg to patients, the overall mean recovery of radioactivity was 89.3%, with a mean recovery of 71.9% in faeces and 17.4% in urine by 288 hours post dose.
Maltese: Wara l-għoti ta' doża orali waħda ta' [14C]-rucaparib 600 mg lill-pazjenti, l-irkupru medju globali tarradjuattività kien 89.3 %, bi rkupru medju ta' 71.9 % fl-ippurgar u 17.4 % fl-awrina b'288 siegħa wara d-doża.
English: A potential risk cannot be ruled out based on the safety margin observed.
Maltese: Jista' jkun hemm riskju potenzjali bbażat fuq il-marġni tas-sigurtà osservat.
English: Adverse reactions leading to permanent discontinuation occurred in 10% of patients, with thrombocytopenia, nausea, anaemia, and fatigue/asthenia being the most frequent adverse reactions leading to permanent discontinuation.
Maltese: Reazzjonijiet avversi li wasslu għall-twaqqif permanenti seħħew f'10% tal-pazjenti, bi tromboċitopenija, dardir, anemija, u għeja/astenija li kienu l-aktar reazzjonijiet avversi frekwenti li jwasslu għal twaqqif permanenti.
English: Rucaparib showed no effect on Cmax of digoxin while marginally increasing AUC0-72h by 1.20 fold (90% CI: 1.12 to 1.29).
Maltese: Rucaparib ma wera l-ebda effett fuq is-Cmax ta' digoxin, filwaqt li jiżdied marġinalment l-AUC0-72h b'1.20 darbiet (90% CI: 1.12 sa 1.29).
English: Adverse reactions that most commonly led to dose reduction or interruption were anaemia (20%), fatigue/asthenia (18%), nausea (16%), thrombocytopenia (15%), and AST/ALT elevations (10%).
Maltese: Ir-reazzjonijiet avversi bl-aktar mod komuni wasslu għal tnaqqis jew interruzzjoni tad-doża kienu tromboċitopenija (15%), anemija (20%), dardir (16%), u żidiet fl-AST/ALT (10%), u għeja/astenija
English: No interaction with MRP2 or MRP3 was observed in vitro at the clinical exposure of rucaparib, however, mild bi-phasic activation and inhibition of MRP2 and concentration dependent inhibition of MRP3 were observed at concentrations higher than the observed plasma Cmax of rucaparib.
Maltese: Ma ġiet osservata l-ebda interazzjoni ma' MRP2 jew MRP3 in vitro flesponiment kliniku ta' rucaparib, madankollu, attivazzjoni u inibizzjoni bifażiċi ħfief ta' MRP2 u inibizzjoni dipendenti fuq il-konċentrazzjoni ta' MRP3, ġew osservati f'konċentrazzjonijiet ogħla mis
English: Yellow, 8 x 16 mm, oval film-coated tablet, debossed with “C3”.
Maltese: Pillola miksija b'rita ovali u safra, 8 x 16 mm, imnaqqxa b' “C3”.
English: The primary tumour in most patients was ovarian (84%); most patients (95%) had serous histology and 4% of patients reported endometrioid histology.
Maltese: It-tumur primarju f'ħafna mill-pazjenti kien ovariku (84%); ħafna mill-pazjenti (95%) kellhom istoloġija seruża u 4 % tal-pazjenti rrappurtaw istoloġija endometrijojda.
English: vomiting, anaemia, abdominal pain, dysgeusia, ALT elevations, AST elevations, decreased appetite, diarrhoea, thrombocytopenia and creatinine elevations.
Maltese: għeja/astenija, rimettar, anemija, uġigħ addominali, tibdil fis-sens tat-togħma, żidiet fl-ALT/żidiet flAST, tnaqqis fl-aptit, , dijarea, tromboċitopenja u żidiet fil-kreatinina.
English: Thus, the risk for clinically significant QTcF increase from baseline (i.e. > 20 msec) is low.
Maltese: Għaldaqstant, ir-riskju għal żieda klinikament sinifikanti fil-QTcF mil-linja bażi (i.e. > 20 msek) huwa baxx.
English: Photosensitivity
Maltese: Ġenotossiċità
English: Effect of P-gp and BCRP inhibitors on rucaparib PK cannot be ruled out.
Maltese: L-effett tal-inibituri ta' P-gp u BCRP fuq il-PK rucaparib ma jistax jiġi eskluż.
English: For the platinum-resistant population (N=20), ORR by investigator review was 35.0% (95% CI [15.4, 59.2], with a complete response rate of 5.0%, and a partial response rate of 30.0%.
Maltese: 35.0% (95% CI [15.4, 59.2], b'rata ta' rispons sħiħ ta' 5.0%, u rata ta' rispons parzjali ta' 30.0%.
English: Hypercholesterolaemiab, Dehydration
Maltese: Iperkolesterolemijab Deidratazzjoni
English: The clinical relevance of UGT1A1 inhibition by rucaparib is not clear.
Maltese: Ir-rilevanza klinika tal-inibizzjoni UGT1A1 minn rucaparib mhix ċara.
English: Increased transaminases
Maltese: Żieda fit-transaminases