FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Postoje ograničeni klinički podaci u bolesnica s umjerenim ili teškim oštećenjem funkcije jetre (tj. svaka vrijednost ukupnog bilirubina veća od 1,5-struke vrijednosti GGN), stoga se rukaparib ne preporučuje za primjenu u bolesnica s umjerenim ili teškim oštećenjem funkcije jetre.
English: • medicines to treat stomach problems - such as cisapride, omeprazole
Croatian: • lijekove za liječenje želučanih problema - kao što je cisaprid, omeprazol
English: • anticoagulant medicines which helps the blood flow freely, such as warfarin
Croatian: • antikoagulanse koji pomažu u nesmetanom protoku krvi - kao što je varfarin
English: The primary efficacy outcome was investigator-assessed progression-free survival (invPFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1).
Croatian: Response Evaluation Criteria in Solid Tumours, RECIST), verzija 1.1 (v1.1).
English: In vitro, rucaparib is metabolised primarily by CYP2D6, and to a lesser extent by CYP1A2, and CYP3A4.
Croatian: In vitro, rukaparib se metabolizira primarno pomoću CYP2D6, a u manjoj mjeri pomoću CYP1A2 i CYP3A4.
English: CI: Confidence interval
Croatian: NP: Nije postignuto CI: Interval pouzdanosti
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%).
Croatian: U bolesnica s umjereno oštećenom funkcijom bubrega (CLcr od 30-59 ml/min), učestalosti nekih nuspojava su se povećale: anemija 3. ili 4. stupnja (31 %), trombocitopenija 3. ili 4. stupnja (12 %) i umor/astenija 3. stupnja (15 %) bile su više nego u bolesnica sa umjereno oštećenom funkcijom bubrega (CLcr > 59-80 ml/min) ili normalnom funkcijom bubrega (CLcr > 80 ml/min) (21 %, 5 % i
English: Data suggest that rucaparib is a moderate inhibitor of CYP1A2, and a mild inhibitor of CYP2C9, CYP2C19, and CYP3A.
Croatian: Podaci ukazuju da je rukaparib umjereni inhibitor CYP1A2 i blagi inhibitor CYP2C9, CYP2C19 i CYP3A.
English: • medicines used to treat asthma - such as theophylline
Croatian: • lijekove koji se koriste za liječenje astme - kao što je teofilin
English: Caution should be exercised and additional International Normalised Ratio (INR) monitoring with co-administration of warfarin and therapeutic drug level monitoring of phenytoin should be considered, if used concomitantly with rucaparib.
Croatian: International Normalised Ratio, INR) kod istodobne primjene varfarina odnosno praćenje terapijske razine fenitoina ako se primjenjuje istodobno s rukaparibom.
English: A population PK analysis was performed to evaluate the effect of renal impairment on the clearance of rucaparib in patients receiving rucaparib 600 mg twice daily.
Croatian: Populacijska PK analiza provedena je za procjenu učinka oštećenja funkcije jetre na klirens rukapariba u bolesnica koje su primale 600 mg dva puta dnevno.
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.
Croatian: Pri eksplorativnoj analizi zabilježen je odgovor u 38 % (95 % CI 23 % - 54 %) ispitanica (n = 15) za rukaparib u odnosu na 9 % (95 % CI 1 % - 28 %) ispitanica (n = 2) za placebo (dvostrana p vrijednost = 0,0055), uključujući 7 ispitanica (18 %) u skupini koja je primala rukaparib koje su postigle potpunu remisiju.
English: If a patient vomits after taking Rubraca, the patient should not retake the dose and should take the next scheduled dose.
Croatian: Ako bolesnica povrati nakon uzimanja lijeka Rubraca, ne smije ponovno uzeti dozu već sljedeću dozu treba uzeti u uobičajeno vrijeme predviđeno za sljedeću dozu.
English: Effect of P-gp and BCRP inhibitors on rucaparib PK cannot be ruled out.
Croatian: Učinak P-gp i BCRP inhibitora na PK rukapariba ne može se isključiti.
English: Increased blood creatinine, Hypercholesterolaemiab
Croatian: Manje često povišene vrijednosti kreatinina u krvi, hiperkolesterolemijab
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.
Croatian: Pri istraživačkoj analizi te podskupine zabilježen je odgovor u 18 % (95 % CI 12 % - 26 %) ispitanica (n = 26) koje su primale rukaparib u odnosu na 8 % (95 % CI 3 % - 17 %) ispitanica (n = 5) koje su primale placebo (dvostrana p vrijednost = 0,0069), uključujući 10 ispitanica (7 %) u skupini koja je primala rukaparib koje su postigle potpunu remisiju.
English: Nervous system disorders Very common
Croatian: Poremećaji živčanog sustava Vrlo često disgeuzija, vrtoglavica
English: If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.
Croatian: Ako se potvrdi MDS/AML nakon ispitivanja vezano uz produljenu hematološku toksičnost, s primjenom lijeka Rubraca je potrebno prestati.
English: Median progression-free survival - days (95% CI)
Croatian: Medijan preživljenja bez progresije - u danima (95 % CI)
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).
Croatian: • Ovojnica tablete: - Rubraca 200 mg filmom obložene tablete: Poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 4000 (E1521), talk (E553b), brilliant blue FCF aluminium lake (E133) i indigo carmine aluminium lake
English: • anticonvulsant medicines used to treat fits (seizures) and epilepsy - such as phenytoin
Croatian: • antikonvulzante koji se koriste u liječenju napadaja i epilepsije - kao što je fenitoin
English: Most patients could continue rucaparib with or without treatment modification without recurrence of
Croatian: Većina bolesnica mogla je nastaviti primati rukaparib bez ili uz prilagodbu liječenja a bez ponovne pojave abnormalnosti u testovima funkcije jetre ≥ 3. stupnja.
English: In vitro, rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Croatian: In vitro, rukaparib je snažan inhibitor MATE1 i MATE2-K, umjeren inhibitor OCT1 i slab inhibitor OCT2.
English: Fertility studies have not been conducted with rucaparib.
Croatian: Nisu provedena ispitivanja plodnosti s rukaparibom.
English: Patients with Renal Impairment
Croatian: Bolesnice s oštećenom funkcijom bubrega
English: No studies have been conducted to investigate the pharmacokinetics of rucaparib in paediatric patients.
Croatian: Nisu provedena ispitivanja farmakokinetike rukapariba u pedijatrijskoj populaciji.
English: PFS events, n (%) PFS, median in months (95% CI)
Croatian: PFS, medijan u mjesecima (95
English: There is no requirement for BRCA testing prior to using Rubraca for the maintenance treatment of adult patients with relapsed high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) who are in a complete or partial response to platinum-based chemotherapy.
Croatian: Nije obavezno testiranje na gen BRCA prije primjene lijeka Rubraca za terapiju održavanja u odraslih bolesnica s relapsnim epitelnim rakom jajnika (engl. epithelial ovarian cancer, EOC), jajovoda (engl. fallopian tube cancer, FTC) ili primarnim peritonealnim rakom (engl. primary peritoneal cancer, PPC) visokog gradusa koje imaju potpun ili djelomičan odgovor na kemoterapiju na bazi platine.
English: • Tablet content: Microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica and magnesium stearate.
Croatian: • Sadržaj tablete: mikrokristalična celuloza, natrijev škroboglikolat (vrsta A), koloidni, bezvodni silicijev dioksid i magnezijev stearat
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
Croatian: Ispitivanje djelotvornosti nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Kako bi se dodatno ispitala djelotvornost rukapariba u terapiji održavanja u bolesnica s relapsnim epitelnim rakom jajnika, jajovoda ili primarnim peritonealnim rakom visokog gradusa, koje imaju odgovor (potpuni ili djelomični) na kemoterapiju na bazi platine, nositelj odobrenja treba dostaviti konačnu analizu ukupnog preživljenja (OS) i ažurirane analize za PFS2, interval bez kemoterapije i vrijeme početka sljedećeg antitumorskog liječenja u okviru randomiziranog, dvostruko slijepog ispitivanja faze 3 CO-338-014.
English: Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome, Erythema
Croatian: Često makulo-papularni osip, sindrom palmarno-plantarne eritrodizestezije, eritem
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
Croatian: Karakteristike populacije Ispitivanja 10 na 42 bolesnice bile su: medijan dobi od 57 godina (raspon 42 do 84), bjelkinje (83 %), funkcionalni status prema ECOG-u bio je 0 (62 %) ili 1 (38 %), rak jajnika visokog gradusa (100 %), 3 ili više prethodnih linija kemoterapije (36 %), medijan vremena od dijagnoze raka jajnika iznosio je 43 mjeseca [raspon: 6 - 178], medijan intervala bez progresije od posljednjeg liječenja platinom iznosio je 8,0 mjeseci [raspon: 6,0 - 116,4].
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.
Croatian: U populaciji ITT, 38 % ispitanica (141/375) u skupini koja je primala rukaparib i 35 % ispitanica (66/189) u skupini koja je primala placebo imalo je mjerljivu bolest na početku ispitivanja.
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).
Croatian: ≥ 75 godina, učestalosti nekih nuspojava su se povećale: povišen kreatinin u krvi (32 %), omaglica (20 %), pruritus (15 %) i poremećaj pamćenja (4 %) bile su više nego u bolesnica u dobi
English: This is because Rubraca can cause low blood counts of:
Croatian: To je stoga što pretrage krvi mogu pokazati nizak broj krvnih stanica:
English: Tabulated list of adverse reactions by MedDRA system organ class Adverse reactions
Croatian: Tablični prikaz nuspojava prema MedDRA klasifikaciji organskih sustava Nuspojave
English: Decreased appetite, Increased blood creatinineb
Croatian: Vrlo često smanjen apetit, povišene vrijednosti kreatinina u krvib
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.
Croatian: Na temelju tih rezultata, 70 % (130/186) bolesnica s tBRCA imalo je mutaciju gBRCA, a 30 % (56/186) imalo je somatsku mutaciju gena BRCA.
English: Median duration of responsea - days (95% CI)
Croatian: Medijan trajanja odgovoraa - u danima (95 %
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.
Croatian: Rukaparib je povećao Cmax S-varfarina za 1,05 puta (90% CI: 0,99; 1,12) i AUC0-96h za 1,49 puta (90 % CI: 1,40; 1,58).
English: Microcrystalline cellulose Sodium starch glycolate (Type A) Colloidal anhydrous silica Magnesium stearate
Croatian: Jezgra tablete mikrokristalična celuloza natrijev škroboglikolat (vrsta A) silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: Rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Croatian: Rukaparib je snažan inhibitor MATE1 i MATE2-K, umjeren inhibitor OCT1 te slab inhibitor OCT2.
English: Potential in vivo BCRP inhibition cannot be excluded.
Croatian: Ne može se isključiti potencijalna in vivo BCRP
English: Thrombocytopeniab, Neutropeniab, Febrile neutropenia, Leukopeniab
Croatian: Često trombocitopenijab, neutropenijab, febrilna neutropenija, leukopenijab
English: Increased transaminases
Croatian: Često povišene vrijednosti transaminazab
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:
Croatian: Karakteristike populacije ispitivanja ARIEL2 u 64 bolesnice bile su: medijan dobi od 60 godina (raspon 33 do 80), bjelkinje (75 %), funkcionalno stanje prema Istočnoj kooperativnoj onkološkoj skupini bilo je 0 (61 %) ili 1 (39 %), rak jajnika visokog gradusa (100%), 3 ili više prethodnih linija kemoterapije (78 %), medijan vremena od dijagnoze raka jajnika iznosio je 53 mjeseca [raspon: 22 - 197], medijan intervala bez progresije od posljednjeg liječenja platinom iznosio je 7,6 mjeseci [raspon: 0,7 - 26,5].
English: Summary of primary efficacy findings for patients with BRCA-mutant ovarian cancer who received rucaparib 600 mg twice daily and two or more prior chemotherapy regimens based on investigator assessment of response
Croatian: Tablica 5. Sažetak rezultata primarnog ishoda djelotvornosti na osnovu ispitivačeve procjene odgovora za bolesnice s rakom jajnika s BRCA mutacijama koje su primale rukaparib 600 mg dvaput dnevno i dva ili više prethodnih režima kemoterapije
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
Croatian: Randomizacija je stratificirana prema najboljem odgovoru na posljednju terapiju platinom (potpuni ili djelomični), vremenu do progresije bolesti nakon pretposljednje terapije platinom (6 do ≤ 12 mjeseci i > 12 mjeseci) te statusu tumorskih biomarkera (tBRCA, deficijencija homologne rekombinacije koja nije BRCA [nbHRD] i negativni biomarkeri).
English: Very common
Croatian: Često umorc
English: Tablet coating Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 (E1521)
Croatian: Ovojnica tablete Poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 4000 (E1521)
English: No starting dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba početne doze u bolesnica s blagim ili umjerenim oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Medicinal product interactions
Croatian: Interakcije lijeka
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).
Croatian: HRD uključuje sve ispitanice sa štetnom germinativnom ili somatskom mutacijom u genu BRCA ili ispitanice bez tBRCA s visokim genomskim gubitkom heterozigotnosti, koji utvrđuje test kliničkog ispitivanja (engl.
English: • Rubraca 300 mg film-coated tablets are yellow, oval, film-coated tablets with “C3” marked on one side.
Croatian: • Rubraca 300 mg filmom obložene tablete su žute, ovalne, filmom obložene tablete s oznakom „C3” na jednoj strani.
English: Rubraca 200 mg film-coated tablets Rubraca 250 mg film-coated tablets Rubraca 300 mg film-coated tablets
Croatian: Rubraca 200 mg filmom obložene tablete Rubraca 250 mg filmom obložene tablete Rubraca 300 mg filmom obložene tablete
English: Objective response rate (ORR) N
Croatian: Stopa objektivnog odgovora (ORR) n % (95 % CI)
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.
Croatian: Rubraca je indicirana kao monoterapija u terapiji održavanja kod odraslih bolesnica s relapsnim, na platinu osjetljivim epitelnim rakom jajnika, jajovoda ili primarnim peritonealnim rakom visokog gradusa koje imaju odgovor (potpun ili djelomičan) na kemoterapiju na bazi platine.
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).
Croatian: Rukaparib je povećao Cmax midazolama za 1,13 puta (90 % CI: 0,95; 1,36) i AUCinf za 1,38 puta (90 % CI: 1,13; 1,69).
English: Rubraca contains the active substance rucaparib.
Croatian: Rubraca sadrži djelatnu tvar rukaparib.
English: Iron oxide yellow (E172)
Croatian: (E553b) i žuti željezov oksid (E172).
English: Embryofetal toxicity
Croatian: Embrio-fetalna toksičnost
English: • Rubraca 250 mg film-coated tablets are white, diamond-shaped, film-coated tablets with “C25” marked on one side.
Croatian: • Rubraca 250 mg filmom obložene tablete su bijele, romboidne, filmom obložene tablete s oznakom „C25” na jednoj strani.
English: vomiting, anaemia, abdominal pain, dysgeusia, ALT elevations, AST elevations, decreased appetite, diarrhoea, thrombocytopenia and creatinine elevations.
Croatian: Nuspojave koje se javljaju u ≥ 20 % bolesnica koje primaju rukaparib bile su mučnina, umor/astenija, povraćanje, anemija, bol u abdomenu, disgeuzija, povišene vrijednosti ALT-a, povišene vrijednosti AST-a, smanjen apetit, proljev, trombocitopenija i povišene vrijednosti kreatinina.
English: Uncommon (may affect up to 1 in 100 people):
Croatian: • svrbež Manje često (može se javiti u do 1 na 100 osoba):
English: No starting dose adjustment is required in patients with mild hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba početne doze u bolesnica s blagim oštećenjem funkcije jetre (vidjeti dio 5.2).
English: Caution should be used for concomitant use of strong CYP3A4 inhibitors or inducers.
Croatian: Potreban je oprez prilikom usporedne primjene s jakim inhibitorima ili induktorima
English: Myelodysplastic syndrome/acute myeloid leukaemia
Croatian: Mijelodisplastični sindrom/akutna mijeloična leukemija
English: Yellow, 8 x 16 mm, oval film-coated tablet, debossed with “C3”.
Croatian: Rubraca 300 mg filmom obložena tableta Žuta, 8 x 16 mm, ovalna, filmom obložena tableta s utisnutom oznakom „C3”.
English: • Rubraca 200 mg film-coated tablets are blue, round, film-coated tablets with “C2” marked on one side.
Croatian: • Rubraca 200 mg filmom obložene tablete su plave, okrugle, filmom obložene tablete s oznakom „C2” na jednoj strani.
English: Clovis Oncology France SAS Tél: +33 (0)805631633
Croatian: Tél: +33 (0)805631633 Ireland
English: Population PK analysis suggested that concomitant use of PPIs is unlikely to have clinically meaningful impact on rucaparib PK. A firm conclusion cannot be made regarding the effect of co-administration of rucaparib and PPIs because dose level and time of administration have not been documented in detail for the PPIs.
Croatian: Ne može se donijeti čvrst zaključak o učinku istodobne primjene rukapariba i IPP-a jer razina doze i vrijeme primjene nisu detaljno dokumentirani za IPP-e.
English: Photosensitivity reaction, Rash, Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome
Croatian: Manje često reakcije fotoosjetljivosti, osip, makulo-papularni osip, sindrom palmarnoplantarne eritodizestezije
English: HR (95% CI) p-valueb a. All randomised patients.
Croatian: HR (95 %-tni CI) p-vrijednostb a.
English: 60 film-coated tablets.
Croatian: OBLIK I SADRŽAJ 60 filmom obloženih tableta.
English: 500 mg twice daily (two 250 mg tablets twice daily)
Croatian: 500 mg dva puta dnevno (dvije tablete od 250 mg dva puta dnevno)
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).
Croatian: (5,4 do 7,3 puta više nego kod bolesnica), ali ne i pri niskom Cmax (1,3 to 3,8 puta veći nego kod bolesnica).
English: Adverse reactions CTCAE Grade 3 or higher occurred in 23% (anaemia), 8% (neutropenia) and 6% (thrombocytopenia) of patients.
Croatian: Nuspojave CTCAE stupnja 3. ili više pojavile su se u 23 % (anemija), 8 %
English: Children unde 18 years of age should not be given Rubraca, This medicine has not beem studied in this age group.
Croatian: Djeca i adolescenti Djeca mlađa od 18 godina ne smiju primati lijek Rubraca.
English: How to take Rubraca
Croatian: Kako uzimati lijek Rubraca
English: Dysgeusia, Dizziness
Croatian: Manje često disgeuzija, vrtoglavica
English: • Women who are able to become pregnant must use effective birth control (contraception):
Croatian: • Žene koje mogu zatrudnjeti moraju koristiti učinkovitu kontrolu začeća (kontracepciju): tijekom liječenja lijekom Rubraca i 6 mjeseci nakon uzimanja posljednje doze lijeka Rubraca.
English: Clovis Oncology Italy IT S.r.l.
Croatian: Clovis Oncology Ireland Ltd.
English: Anaemiab, Thrombocytopeniab, Neutropeniab
Croatian: Vrlo često anemijab, trombocitopenijab, neutropenijab,
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.
Croatian: Ovi su se rezultati pojavili pri izloženostima ispod onih opaženih u bolesnica liječenih preporučenom dozom i bili su većinom reverzibilni u roku od 4 tjedna od prestanka doziranja.In vitro, IC50 rukapariba za hERG (engl. humani Ether à- go-go Related Gene) bio je 22,6 µM, što je otprilike 13 puta više nego Cmax kod bolesnica pri preporučenoj dozi.
English: Pyrexia a MDS/AML rate is based on overall total patient population of 1321 who have received one dose of oral rucaparib.
Croatian: Manje često pireksija a Stopa MDS/AML-a temelji se na ukupnoj populaciji od 1321 bolesnice koje su primile jednu dozu oralnog rukapariba b Uključuje laboratorijske nalaze c Uključuje umor, asteniju i letargiju
English: d. tBRCA includes all patients with a deleterious germline or somatic BRCA mutation, as determined by the CTA.
Croatian: Clinical trial assay, CTA). d. tBRCA uključuje sve ispitanice sa štetnom germinativnom ili somatskom mutacijom u genu BRCA,
English: Myelodysplastic syndrome / Acute myeloid leukaemia
Croatian: Često mijelodisplastični sindrom/akutna mijeloična leukemijaa
English: White, 11 x 15 mm, diamond-shaped film-coated tablet, debossed with “C25”.
Croatian: Rubraca 250 mg filmom obložena tableta Bijela, 11 x 15 mm, romboidna, filmom obložena tableta s utisnutom oznakom „C25”.
English: 400 mg twice daily (two 200 mg tablets twice daily)
Croatian: 400 mg dva puta dnevno (dvije tablete od 200 mg dva puta dnevno)
English: 300 mg twice daily (one 300 mg tablet twice daily)
Croatian: 300 mg dva puta dnevno (jedna tableta od 300 mg dva puta dnevno)