natgillin/translations-raw huggingface dataset:
• red blood-cells, white blood-cells, or platelets. 
• rdečih krvnih celic, belih krvnih celic ali krvnih ploščic.
Efficacy results are summarised in Table 4 and Figure 1. 
Rezultati za učinkovitost so povzeti v Preglednici 4 in na sliki 1.
These findings occurred at exposures below those observed in patients treated at the recommended dose, and were largely reversible within 4 weeks of cessation of dosing. 
Ti izsledki so se pojavili pri izpostavljenostih, nižjih od tistih, ki so jih opazili pri bolnicah, zdravljenih s priporočenim odmerkom, in so bili v veliki meri reverzibilni v 4 tednih po prekinitvi odmerjanja.
Investigator Assessment 
Ocena raziskovalca
See section 4 for more information. 
Za več informacij glejte poglavje 4.
In the event of suspected overdose, physicians should follow general supportive measures and should treat symptomatically. 
V primeru suma na preveliko odmerjanje morajo zdravniki uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
The absolute oral bioavailability at 600 mg has not been determined. 
Absolutne peroralne biološke uporabnosti pri odmerku 600 mg niso ugotovili.
There are limited clinical data in patients aged 75 or over. 
Klinični podatki o bolnicah, starih 75 let ali več, so omejeni.
Although no cases were reported during therapy in patients who received placebo, one case has been reported in a placebo - treated patient during the long term safety follow up. 
Čeprav med zdravljenjem pri bolnicah, ki so prejemale placebo, niso poročali o nobenem primeru, so o enem primeru pri bolnici, ki se je zdravila s placebom, poročali med dolgoročnim spremljanjem varnosti.
The majority of adverse reactions were mild to moderate (Grade 1 or 2). 
Večina neželenih učinkov je bila blagih do zmernih (stopnje 1 ali 2).
The only serious adverse reaction occurring in > 2% of patients was anaemia (5%). 
Edini resen neželeni učinek, ki se je pojavil pri > 2 % bolnic, je bil anemija (5 %).
The doses should be taken approximately 12 hours apart. 
Med odmerkoma naj bo približno 12-urni razmak.
Rucaparib may only be used in patients with severe renal impairment if the potential benefit outweighs the risk. 
Rukaparib se sme pri bolnicah s hudo okvaro ledvic uporabljati le, če morebitne koristi odtehtajo tveganja.
For the platinum-refractory population (N=7), there were no responders. 
Med populacijo, neodzivno na platino (N=7), ni bilo odzivnih bolnic.
Patients with changes (mutations) in genes called BRCA are at risk of developing a number of types of cancer. 
Pri bolnicah s spremembami (mutacijami) genov, imenovanih BRCA, obstaja tveganje za pojav številnih vrst raka.
These events occurred within the first few weeks of treatment with rucaparib, were reversible, and were rarely associated with increases in bilirubin. 
Ti dogodki so se pojavili v prvih tednih zdravljenja z rukaparibom, bili so reverzibilni in redko povezani s povišanji bilirubina.
The primary efficacy outcome measure of both studies was objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1. 
Glavno merilo izida učinkovitosti je v obeh študijah predstavljala stopnja objektivnega odziva (objective response rate - ORR), kot jo je ocenil raziskovalec glede na merila RECIST, različica 1.1.
Other minor metabolites accounted for 13.8% of the radioactivity in plasma. 
Drugi manjši presnovki so predstavljali 13,8 % radioaktivnosti v plazmi.
Treatment with rucaparib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. 
Zdravljenje z rukaparibom mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
Following repeated twice daily dosing, the accumulation based on AUC ranged from 3.5 to 6.2 fold. 
Po večkratnem odmerjanju dvakrat na dan je bilo kopičenje glede na vrednost AUC od 3,5- do 6,2-kratno.
Age, race, and body weight 
Starost, rasa in telesna masa
The food effect on PK was not considered clinically significant. 
Učinek hrane na farmakokinetiko se ne šteje za klinično pomembnega.
Recommended dose adjustments Dose reduction 
Priporočene prilagoditve odmerkov Zmanjšanje odmerkov Odmerek
Grade 4 
Stopnja 4
• every month during treatment with Rubraca 
• vsak mesec med zdravljenjem z zdravilom Rubraca
• You can take the tablets with or without food. 
- Tablete lahko vzamete s hrano ali brez nje.
They may stop treatment with Rubraca until your blood cell counts improve. 
Odloči se lahko za prekinitev zdravljenja z zdravilom Rubraca, dokler se število celic v vaši krvi ne izboljša.
Pregnant women should be informed of the potential risk to a foetus. 
Nosečnice je treba opozoriti na potencialno tveganje za plod.
Greater sensitivity of some elderly patients (≥ 65 years of age) to adverse events cannot be ruled out. 
Večje občutljivosti za neželene učinke pri nekaterih starejših bolnicah (≥ 65 let) ni mogoče izključiti.
Breast-feeding (see section 4.6) 
Dojenje (glejte poglavje 4.6)
It is used after the cancer has responded to previous chemotherapy treatments. 
Uporabljamo ga potem, ko se je rak odzval na predhodna zdravljenja s kemoterapijo.
Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the rucaparib and placebo arms. 
Demografski podatki, značilnosti bolezni v izhodišču in zgodovina predhodnih zdravljenj so bili na splošno dobro uravnoteženi med skupinama, ki sta prejemali rukaparib in placebo.
Four (5.1%) of 79 platinum sensitive patients overall had progressive disease as best response. 
Pri štirih (5,1 %) od skupaj 79 na platino občutljivih bolnic je bil najboljši odziv progresivna bolezen.
Steady state was achieved after 1 week of dosing. 
Stanje dinamičnega ravnovesja je bilo doseženo po 1-tedenskem odmerjanju zdravila.
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX55 
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX55
The overall safety profile of rucaparib is based on data from 937 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy. 
Celoten varnostni profil rukapariba temelji na podatkih o 937 bolnicah v kliničnih preskušanjih za raka jajčnikov, zdravljenih z monoterapijo rukapariba.
Rubraca blocks an enzyme that repairs damaged DNA in the cancer cells, resulting in their death. 
Zdravilo Rubraca blokira encim, ki popravlja poškodovano DNK v rakavih celicah, in tako povzroči njihovo smrt.
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. 
V študijah toksičnosti s ponavljajočimi odmerki pri podganah in psih, ki so trajale do 3 mesece, so bili ciljni organi gastrointestinalni, hematopoetski in limfopoetski sistemi.
Increases in serum aminotransferases (AST/ALT) 
Povišanja aminotransferaz v serumu (AST/ALT)
All patients had potential contributing factors for the development of MDS/AML; in all cases, patients had received previous platinumcontaining chemotherapy regimens and/or other DNA damaging agents. 
Vse bolnice so imele dejavnike, ki bi lahko pripomogli k razvoju MDS/AML; v vseh primerih so bolnice v preteklosti prejemale kemoterapevtske režime zdravljenja s platino in/ali druga zdravila, ki poškodujejo DNA.
Complete response % Partial response % 
Popolni odziv %
The clinical relevance MRP2 and MRP3 interaction in the gut is not known. 
Klinični pomen interakcije MRP2 in MRP3 v prebavilih ni znan.
Central BRCA testing was performed retrospectively after patients were enrolled. 
Osrednje testiranje BRCA je bilo opravljeno retrospektivno po vključitvi bolnic.
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. 
Priporočeni odmerek je 600 mg rukapariba dvakrat na dan, kar ustreza celotnemu dnevnemu odmerku 1.200 mg, jemati pa ga je treba do napredovanja bolezni ali do nesprejemljive toksičnosti.
Rubraca should not be used during pregnancy unless the clinical condition of the woman requires treatment with rucaparib. 
Zdravila Rubraca se med nosečnostjo ne sme uporabljati, razen če klinično stanje nosečnice zahteva zdravljenje z rukaparibom.
Four (0.4%) patients reported a CTCAE Grade 3 reaction. 
Pri štirih (0,4 %) bolnicah so poročali o učinku stopnje CTCAE 3.
The mean half-life (t1/2) of rucaparib was 25.9 hours. 
Mediani razpolovni čas (t1/2) rukapariba je bil 25,9 ur.
Patients were randomised within 8 weeks of completion of platinum chemotherapy and no intervening maintenance treatment was permitted. 
Bolnice so bile randomizirane v 8 tednih od zaključka kemoterapije na osnovi platine, dovoljeno pa ni bilo nikakršno interventno vzdrževalno zdravljenje.
• If you are sick (vomit) after taking Rubraca, do not take an extra dose. 
- Če vam je slabo (bruhate) po tem, ko ste vzeli zdravilo Rubraca, ne vzemite dodatnega odmerka.
Frequencies of occurrence of adverse reactions 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 < 1/1000); very rare 
Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (<1/10.000), neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
No events met Hy's Law criteria for drug-induced liver injury. 
Nobeden od dogodkov ni ustrezal merilom Hyjevega zakona za poškodbe jeter zaradi zdravil.
Elevations in serum creatinine 
Zvišane ravni kreatinina v serumu
The European Medicines Agency has waived the obligation to submit the results of studies with Rubraca in all subsets of the paediatric population in ovarian cancer (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Rubraca za vse podskupine pediatrične populacije pri raku jajčnikov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines. 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• a low blood-cell count may be a sign of a serious bone marrow problem - such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML). 
• nizko število krvnih celic je lahko znak resnejše težave s kostnim mozgom, na primer „mielodisplastičnega sindroma“ (MDS) ali “akutne mieloične levkemije“ (AML).
Decreased appetite, Dehydration 
Pogosti zmanjšan apetit, dehidracija
No significant P-gp inhibition was observed in vivo (section 4.5). 
In vivo niso opazili pomembnega zaviranja P-gp (poglavje 4.5).
ARIEL3 demonstrated a statistically significant improvement in PFS for patients randomised to rucaparib as compared with placebo in the ITT population and in the HRD and tBRCA subgroups. 
Študija ARIEL3 je pokazala statistično značilno izboljšanje PFS pri bolnicah, randomiziranih v rukaparib, v primerjavi s placebom pri populaciji ITT in v podskupinah HRD ter tBRCA.
Women of childbearing potential/contraception in females 
Ženske v rodni dobi/kontracepcija pri ženskah
Tell your doctor, pharmacist or nurse if you are taking any of the following medicines: 
Zdravniku, farmacevtu ali medicinski sestri morate povedati, če jemljete katero od naslednjih zdravil:
Kaplan-Meier Curves of Progression-Free Survival in ARIEL3 as Assessed by Investigator: ITT population 
Slika 1: Kaplan-Meierjeve krivulje preživetja brez napredovanja bolezni pri ARIEL3 po oceni raziskovalca - populacija ITT
If the levels have not recovered to CTCAE Grade 1 or better after 4 weeks, the patient should be referred to a haematologist for further investigations. 
Če se vrednosti v 4 tednih ne popravijo vsaj na stopnjo 1 po CTCAE, je treba bolnico napotiti k hematologu na nadaljnje preiskave.
In the pivotal Phase 3 study (ARIEL3), the incidence of MDS/AML during therapy in patients who received rucaparib was 0.8%. 
V ključni študiji 3. faze (ARIEL3) je pojavnost MDS/AML med zdravljenjem pri bolnicah, ki so prejemale rukaparib, znašala 0,8 %.
months), and tumour biomarker status (tBRCA, non-BRCA homologous recombination deficiency [nbHRD] and biomarker negative). 
mesecev in več kot 12 mesecev) ter statusa biomarkerja za tumor (tBRCA, homologno rekombinatorno pomanjkanje, ki ni povezano z BRCA [nbHRD] in negativni biomarker).
HDPE bottle, with a polypropylene (PP) induction seal closure, containing 60 tablets. 
Plastenka iz HDPE z indukcijsko zapečateno zaporko iz propilena (PP), ki vsebuje 60 tablet.
Rubraca is for oral use and can be taken with or without food. 
Zdravilo Rubraca je namenjeno za peroralno uporabo in ga je mogoče jemati s hrano ali brez nje.
• use a sunscreen and lip balm with a sun protection factor (SPF) of 50 or higher. 
• zaščititi s sredstvom za zaščito pred soncem in z balzamom za ustnice z zaščitnim faktorjem (SPF) 50 ali več.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http:// www.ema.europa.eu.
Patients with moderate or severe renal impairment should be carefully monitored for renal function and adverse reactions. 
Bolnice z zmerno ali hudo okvaro ledvic je treba skrbno spremljati glede delovanja ledvic in neželenih učinkov.
Rucaparib preferentially distributed to red blood cells with a blood-to-plasma concentration ratio of 1.83. 
Rukaparib se je prednostno porazdelil v rdeče krvničke, razmerje koncentracij v krvi in plazmi je bilo 1,83.
Ninety percent of the observed faecal recovery was achieved within 168 hours postdose. 
Devetdeset odstotkov izločka v blatu je bilo zaznanega v 168 urah po odmerjanju.
• The other ingredients are: 
Druge sestavine zdravila so:
Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib. 
O mielodisplastičnem sindromu/akutni mieloični levkemiji (MDS/AML), vključno s primeri s smrtnim izidom, so poročali pri bolnicah, ki so prejemale rukaparib.
If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued. 
Če je po preiskavi dolgotrajnejše hematološke toksičnosti potrjena diagnoza MDS/AML, je treba zdravljenje z zdravilom Rubraca prekiniti.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom, preden vzamete to zdravilo.
• The usual recommended dose is 600 mg twice a day. 
- Običajni priporočeni odmerek je 600 mg dvakrat na dan.
Dose adjustments may be considered, if clinically indicated based on observed adverse reactions. 
Morda bo treba razmišljati o prilagoditvi odmerkov, če bo to klinično indicirano glede na opažene neželene učinke.
• Do not take a double dose to make up for a forgotten dose. 
• Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Other moderate to severe non-haematological adverse reactions such as nausea and vomiting, can be managed through dose interruption and/or reductions, if not adequately controlled by appropriate symptomatic management. 
Druge zmerne do hude nehematološke neželene učinke, kot sta npr. navzea ali bruhanje, je mogoče obvladovati s prekinitvijo in/ali zmanjšanji odmerkov, če jih z ustreznim simptomatskim zdravljenjem ni mogoče zadovoljivo obvladati.
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). 
Vzorec tumorskih tkiv vseh bolnic (N = 564) je bil centralno testiran za ugotavljanje pozitivnega stanja HRD (ki ga opredeljuje prisotnost mutacije škodljivega tumorja BRCA [tBRCA] ali visoke genomske izgube heterozigotnosti).
If you take Rubraca because your cancer has progressed you will need to have a clinical test to identify an abnormality in the BRCA gene. 
Če zdravilo Rubraca jemljete, ker je vaš rak napredoval, boste morali na klinično preiskavo za ugotavljanje nenormalnosti v genu BRCA.
Grade 1-3 elevations in AST/ALT can be managed without change to the rucaparib dose, or with treatment modification (interruption and/or dose reduction). 
Zvišane ravni AST/ALT stopenj od 1 do 3 je mogoče obvladovati brez spreminjanja odmerka rukapariba ali s prilagoditvijo zdravljenja (prekinitev in/ali zmanjšanje odmerka).
The risk for a clinically relevant effect of concomitant administration of proton pump inhibitors (PPIs) is likely small (see section 5.2). 
Verjetno je tveganje za klinično pomembne učinke sočasnega dajanja zaviralcev protonske črpalke (proton pump inhibitors - PPI) majhno (glejte poglavje 5.2).
Detection of BRCA mutation 
Zaznava mutacije BRCA
Pregnancy/contraception 
Nosečnost/kontracepcija
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. 
Rukaparib je zaviralec encimov poli(ADP-riboza) polimeraze (PARP), vključno s PARP-1, PARP-2 in PARP-3, ki sodelujejo pri popravilu DNA.
The median duration of response was 196 days (95% CI [113 - NA]). 
Mediano trajanje odziva je bilo 196 dni (95-% IZ [113 - NA]).
As such, efficacy of Rubraca in patients who have received prior treatment with a PARP inhibitor in the maintenance setting, has not been investigated and cannot be extrapolated from the available data. 
Učinkovitost zdravila Rubraca pri bolnicah, ki so predhodno prejemale vzdrževalno zdravljenje z zaviralcem PARP, zato ni bila raziskana in je ni mogoče ekstrapolirati iz razpoložljivih podatkov.
Following administration of a single oral dose of [14C]-rucaparib to patients with solid tumours, unchanged rucaparib accounted for 64.0% of the radioactivity in plasma. 
Po dajanju enega samega peroralnega odmerka [14C]-rukapariba bolnikom s solidnimi tumorji je nespremenjen rukaparib predstavljal 64,0 % radioaktivnosti v plazmi.
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). 
Poleg tega je rukaparib zaviralec BCRP z vrednostjo IC50, ki kaže na potencialno zaviranje BCRP in povečano izpostavljenosti zdravilom, ki so substrati BCRP (npr. rosuvastatin).
The pharmacokinetic characteristics of rucaparib in patients with CLcr less than 30 mL/min or patients on dialysis are unknown (see section 4.2). 
Farmakokinetične značilnosti rukapariba pri bolnicah s CLcr manj kot 30 ml/min ali pri bolnicah na dializi niso znane (glejte poglavje 4.2).
AST/ALT elevations may need to be managed with treatment interruption and/or dose reduction as described in Table 2 (see section 4.2). 
Zvišane ravni AST/ALT bo morda treba uravnavati s prekinitvijo zdravljenja in/ali zmanjšanjem odmerka, kot je predstavljeno v preglednici 2 (glejte poglavje 4.2).
This is because rucaparib may affect the unborn baby. 
To je nujno zato, ker lahko rukaparib škoduje nerojenemu otroku.
All patients had received at least two prior platinum-based chemotherapies (range: 2 to 6) and 28% of patients had received at least three prior platinum-based chemotherapies. 
Vse bolnice so prejele vsaj dve predhodni kemoterapiji na osnovi platine (razpon: 2-6), 28 % bolnic pa je prejelo vsaj tri predhodne kemoterapije na osnovi platine.
If MDS/AML is suspected, the patient should be referred to a haematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. 
Če sumite na pojav MDS/AML, morate bolnico napotiti k hematologu na nadaljnje preiskave, vključno z analizo kostnega mozga in z odvzemom vzorca krvi za citogenetsko analizo.
Elevations in creatinine with rucaparib treatment may be due to inhibition of the renal transporters MATE1 and MATE2-K (see section 4.5). 
Do zvišanih ravni kreatinina pri zdravljenju z rukaparibom lahko prihaja zaradi zaviranja ledvičnih prenašalcev MATE1 in MATE2-K (glejte poglavje 4.5).
If you take more Rubraca than you should 
Če ste vzeli večji odmerek zdravila Rubraca, kot bi smeli
The findings in non-clinical toxicology studies performed with oral rucaparib were generally consistent with the adverse events observed in clinical studies. 
Ugotovitve nekliničnih toksikoloških študij, izvedenih s peroralnim rukaparibom, so bile v splošnem skladne z neželenimi učinki, ugotovljenimi v kliničnih študijah.
Thrombocytopenia and anaemia led to discontinuation in 1.8% and 2.1% of patients. 
Trombocitopenija in anemija sta vodili v prekinitev zdravljenja pri 1,8 % in 2,1 % bolnic.
The mean absolute oral bioavailability following a single oral dose of 12 to 120 mg rucaparib was 36%. 
Mediana absolutna peroralna biološka uporabnost po enkratnem peroralnem odmerku od 12 do 120 mg rukapariba je bila 36 %.
What Rubraca is and what it is used for What you need to know before you take Rubraca How to take Rubraca 
Kaj je zdravilo Rubraca in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Rubraca Kako jemati zdravilo Rubraca
Although no cardiac effects were observed following oral dosing, based on the findings in the intravenous studies and safety margins, cardiac effects in patients cannot be excluded when rucaparib is given orally. 
Čeprav po peroralnem odmerjanju niso opazili učinkov na srce, pa na podlagi izsledkov iz študij z intravenskim dajanjem in na podlagi varnostnih omejitev ni mogoče izključiti učinkov na srce pri bolnicah, ki peroralno prejemajo rukaparib.
The primary tumour in most patients was ovarian (84%); most patients (95%) had serous histology and 4% of patients reported endometrioid histology. 
Primarni tumor pri večini bolnic je bil tumor jajčnikov (84 %); večina bolnic (95 %) je imela serozno histologijo in pri 4 % bolnic so poročali o endometrijski histologiji.
Patients should not start Rubraca treatment until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1). 
Bolnice ne smejo začeti zdravljenja z zdravilom Rubraca, dokler ne okrevajo po hematotoksičnih učinkih predhodne kemoterapije (stopnje ≤ 1 po CTCAE).
This is because Rubraca can affect the way some other medicines work. 
Zdravilo Rubraca namreč lahko vpliva na delovanje nekaterih drugih zdravil.
Grade 4 reactions require treatment modification (see Table 2). 
Učinki stopnje 4 zahtevajo prilagoditev zdravljenja (glejte preglednico 2).
Also some other medicines can affect the way Rubraca works. 
Tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Rubraca.
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. 
Zvišane ravni kreatinina v serumu, večinoma blage do zmerne (stopnje 1 ali 2 po CTCAE), so opažali pri 20 % bolnic v prvih tednih zdravljenja z rukaparibom.
PFS events, n (%) PFS, median in months (95% CI) 
Dogodki PFS, n (%) PFS, mediana v mesecih (95-% IZ)
Rubraca should be interrupted or dose reduced according to Table 1 (see section 4.2) and blood counts monitored weekly until recovery. 
Zdravljenje z zdravilom Rubraca je treba prekiniti ali zmanjšati odmerek zdravila v skladu s Preglednico 1 (glejte poglavje 4.2), krvno sliko pa spremljati na tedenski osnovi do okrevanja.
Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient. 
Do zvišanih ravni jetrnih transaminaz (aspartat-aminotransferaze (AST) in/ali alanin-aminotransferaze (ALT)) prihaja v zgodnjem obdobju zdravljenja in so običajno prehodne narave.