natgillin/translations-raw huggingface dataset:
The median duration of response was 196 days (95% CI [113 - NA]).
Medijan trajanja odgovora bio je 196 dana (95 % CI [113 - NA]).
Based on population PK analysis, no clinically significant relationships were identified between predicted steady-state exposure and patient's age, race, and body weight.
Na temelju populacijske PK analize, nisu identificirani klinički značajni odnosi između predviđene izloženosti u stanju dinamičke ravnoteže i dobi, rase i tjelesne težine bolesnika.
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.
Sve bolesnice imale su potencijalne faktore koji su doprinijeli razvoju MDS/AML-a; u svim slučajevima bolesnice su prethodno primile režim kemoterapije koji sadrži platinu i/ili druge lijekove koji oštećuju DNK.
No adjustment is recommended to the starting dose for elderly patients (≥ 65 years of age) (see sections 4.8 and 5.2).
Ne preporučuje se prilagodba početne doze za starije bolesnice (u dobi od ≥ 65 godina) (vidjeti dijelove 4.8 i 5.2).
What Rubraca is and what it is used for What you need to know before you take Rubraca How to take Rubraca
Što je Rubraca i za što se koristi Što morate znati prije nego počnete uzimati lijek Rubraca Kako uzimati lijek Rubraca
Kaplan-Meier Curves of Progression-Free Survival in ARIEL3 as Assessed by Investigator: ITT population
Slika 1. Kaplan-Meierove krivulje preživljenja bez progresije bolesti u ispitivanju ARIEL 3 prema procjeni ispitivača: ITT populacija
Rubraca is for oral use and can be taken with or without food.
Rubraca je namjenjena za peroralnu primjenu i može se uzeti sa ili bez hrane.
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.
Nisu opaženi učinci na plodnost mužjaka i ženki u 3-mjesečnim ispitivanjima opće toksikologije na štakorima i psima pri izloženosti od 0,09 do 0,3 puta AUC-a u ljudi pri preporučenoj dozi.
The primary efficacy outcome measure of both studies was objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1.
Mjera primarnog ishoda djelotvornosti u oba ispitivanja bila je stopa objektivnog odgovora (objective response rate, ORR) prema procjeni ispitivača u skladu s verzijom 1.1. RECIST-a.
Interaction of rucaparib with other enzymes and transporter was evaluated in vitro.
Interakcija rukapariba s drugim enzimima i transporterima procijenjena je in vitro.
Effect of other medicinal products on rucaparib
Učinak drugih lijekova na rukaparib
In vitro studies have shown that rucaparibinduced cytotoxicity involves inhibition of PARP enzymatic activity and the trapping of PARP-DNA complexes resulting in increased DNA damage, apoptosis, and cell death.
In vitro ispitivanja pokazala su da citotoksičnost izazvana rukaparibom uključuje inhibiciju enzimske aktivnosti PARP-a i hvatanje PARP-DNK kompleksa što dovodi do povećanog oštećenja DNK-a, apoptoze i smrti stanice.
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 inhibitor enzima poli(ADP-riboza) polimeraze (PARP), uključujući PARP-1, PARP-2 i PARP-3, koji igra ulogu u popravku DNK-a.
Women of childbearing potential/contraception in females
Žene u reproduktivnoj dobi/kontracepcija u žena
Rubraca can be used as maintenance therapy immediately after a course of chemotherapy that has caused the tumour to shrink.
Rubraca se može primjenjivati kao terapija održavanja odmah nakon ciklusa kemoterapije kojom je postignuto smanjenje tumora.
In the pivotal Phase 3 study (ARIEL3), the incidence of MDS/AML during therapy in patients who received rucaparib was 0.8%.
U pivotalnom ispitivanju faze 3 (ARIEL3) incidencija MDS/AML-a tijekom liječenja u bolesnica koje su primale rukaparib iznosila je 0,8 %.
The mean absolute oral bioavailability following a single oral dose of 12 to 120 mg rucaparib was 36%.
Srednja vrijednost apsolutne peroralne bioraspoloživosti nakon jedne peroralne doze od 12 do 120 mg rukapariba bila je 36 %.
Rubraca is used to treat a type of cancer of the ovary.
Rubraca se koristi za liječenje jedne vrste raka jajnika.
Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate neke od sljedećih lijekova:
Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anaemia and neutropenia.
Potrebno je primijeniti suportivnu njegu i smjernice ustanove za zbrinjavanje niskog broja krvnih stanica s ciljem liječenja anemije i neutropenije.
The clinical relevance of UGT1A1 inhibition by rucaparib is not clear.
Klinička relevantnost inhibicije UGT1A1 rukaparibom nije jasna.
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.
Nije opažena nikakva interakcija s MRP2 ili MRP3 in vitro pri kliničkoj izloženosti rukaparibu, međutim, blaga bi-fazna aktivacija i inhibicija MRP2 i inhibicija MRP3 ovisna o koncentraciji opažene su pri koncentracijama višim od uočenog Cmax rukapariba u plazmi.
The pharmacokinetic characteristics of rucaparib in patients with CLcr less than 30 mL/min or patients on dialysis are unknown (see section 4.2).
Farmakokinetičke karakteristike rukapariba u bolesnica s CLcr manjim od 30 ml/min ili bolesnica na dijalizi nisu poznate (vidjeti dio 4.2).
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).
Europska agencija za lijekove izuzela je obavezu podnošenja rezultata ispitivanja lijeka Rubraca u svim podskupinama pedijatrijske populacije za rak jajnika (vidjeti dio 4.2 za informacije o primjeni u pedijatriji).
Rubraca should be interrupted or dose reduced according to Table 1 (see section 4.2) and blood counts monitored weekly until recovery.
Primjenu doza lijeka Rubraca treba prekinuti ili smanjiti dozu prema Tablici 1 (vidjeti dio 4.2) i svaki tjedan pratiti broj krvnih stanica sve do oporavka.
Rubraca can also be used if your cancer has progressed after chemotherapy has been used and you have an abnormality of the BRCA gene.
Rubraca se također može primjenjivati ako je Vaš rak napredovao nakon primjene kemoterapije a imate abnormalnost gena BRCA.
Also some other medicines can affect the way Rubraca works.
Također, neki drugi lijekovi mogu utjecati na djelovanje lijeka Rubraca.
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.
Iako u bolesnica koje su primale placebo nije prijavljen nijedan slučaj za samo vrijeme trajanja njegove primjene, jedan slučaj u bolesnice koja je primala placebo prijavljen je tijekom dugoročnog sigurnosnog praćenja.
All patients had achieved a response (complete or partial) to their most recent platinum-based chemotherapy and their cancer antigen 125 (CA-125) was below the upper limit of normal (ULN).
Sve bolesnice postigle su odgovor (potpun ili djelomičan) na zadnju kemoterapiju na bazi platine a karcinomski antigen 125 (CA-125) bio im je ispod gornje granice normale (GGN).
The overall safety profile of rucaparib is based on data from 937 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy.
Cjelokupni sigurnosni profil rukapariba temelji se na podacima iz kliničkih ispitivanja raka jajnika u 937 bolesnica liječenih monoterapijom rukaparibom.
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 umjerene do teške nehematološke nuspojave poput mučnine i povraćanja mogu se zbrinjavati prekidima primjene doza i/ili smanjenjem doze ako se adekvatno ne kontroliraju odgovarajućim zbrinjavanjem simptoma.
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.
Potreban je oprez prilikom istodobne primjene rukapariba i supstrata UGT1A1 (tj. irinotekana) kod pacijenata s UGT1A1*28 (slab metabolizator) radi mogućeg povećanja izlaganju SN-38 (aktivnom metabolitu irinotekana) i povezanom toksičnošću.
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.
Gastrointestinalne toksičnosti (mučnina i povraćanje) često prijavljene s rukaparibom, općenito su niskog stupnja (CTCAE 1. ili 2. stupnja) i mogu se zbrinjavati smanjenjem doze (vidjeti Tablicu 1) ili prekidom.
P-gp substrates
Supstrati P-gp
Each bottle contains 60 film-coated tablets.
Jedna boca sadrži 60 filmom obloženih tableta.
For risk mitigation and management, see section 4.4.
Za ublažavanje rizika i zbrinjavanje, vidjeti dio 4.4.
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.
Iako nisu uočeni kardiološki učinci nakon peroralnog doziranja lijeka, na temelju rezultata ispitivanja s intravenskom primjenom i granica sigurnosti, kardiološki učinci u bolesnica ne mogu se isključiti pri peroralnom davanju rukapariba.
Clovis Oncology Ireland Ltd. Regus Dublin Airport Skybridge House - Dublin Airport Swords
Regus Dublin Airport Skybridge House - Dublin Airport Swords
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).
Uzorci tumorskog tkiva za sve bolesnice (N = 564) centralno su testirani kako bi se utvrdio pozitivan HRD status (kako se definira prisutnošću štetne mutacije gena BRCA [tBRCA] u tumorskom tkivu ili visokim genomskim gubitkom heterozigotnosti).
Talk to your doctor if you feel sick (nauseous), have been sick (vomiting) or you have had diarrhoea.
Razgovarajte sa svojim liječnikom ako imate mučninu, povraćanje ili ste imali proljev.
The most abundant metabolite was M324, an oxidative deamination product of rucaparib, accounting for 18.6% of the radioactivity in plasma.
Najobilniji metabolit bio je M324, produkt rukapariba koji nastaje oksidativnom deaminacijom i odgovoran je za 18,6 % radioaktivnosti u plazmi.
Ninety percent of the observed faecal recovery was achieved within 168 hours postdose.
Devedest posto zabilježenog fekalnog oporavka postignuto je unutar 168 sati nakon doze.
The duration of therapy with rucaparib in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.
Trajanje terapije rukaparibom u bolesnica koje su razvile MDS/AML variralo je u rasponu od manje od 1 mjeseca do približno 28
The time of onset for adverse reactions of myelosuppression Grade 3 or higher was generally later in treatment (after 2 or more months).
Vrijeme do početka nuspojava mijelosupresije stupnja 3. ili više bilo je uglavnom kasnije u liječenju (nakon 2 ili više mjeseci).
Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor.
Djelotvornost lijeka Rubraca kao terapije za relapsni ili progresivni EOC, FTC ili PPC nije ispitana u bolesnica koje su primile prethodno liječenje inhibitorom PARP-a.
Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient.
Povišene vrijednosti jetrenih transaminaza (aspartat aminotransferaze (AST) i/ili alanin aminotransferaze (ALT)) javljaju se ranije tijekom liječenja i uglavnom su prolazne.
Interrupt treatment if AST/ALT levels do not decline within 2 weeks until Grade ≤ 2, then resume rucaparib at the same or at a reduced dose
Prekid liječenja ako se razine AST-a/ALT-a ne smanje unutar 2 tjedna do ≤ 2. stupnja, zatim nastavak primjene rukapariba u istoj ili smanjenoj dozi
Increased alanine aminotransferase, Increased aspartate aminotransferase
Često povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze
Haematological adverse reactions of all CTCAE Grades of anaemia, thrombocytopenia and neutropenia were reported in 42%, 26% and 16% of patients respectively.
Hematološke nuspojave svih CTCAE stupnjeva anemije, trombocitopenije i neutropenije prijavljene su u 42 %, 26 % i 16 % bolesnika.
Rucaparib preferentially distributed to red blood cells with a blood-to-plasma concentration ratio of 1.83.
Rukaparib se preferencijalno distribuira u eritrocite s omjerom koncentracije krvplazma od 1,83.
The findings in non-clinical toxicology studies performed with oral rucaparib were generally consistent with the adverse events observed in clinical studies.
Rezultati nekliničkih toksikoloških ispitivanja provedenih s oralnim rukaparibom bili su uglavnom dosljedni štetnim događajima opaženim u kliničkim ispitivanjima.
IRR- assessment for the ITT population supported the primary endpoint.
Independent radiology review) za ITT populaciju podupirala je primarni ishod.
• If you are sick (vomit) after taking Rubraca, do not take an extra dose.
• Ako povraćate nakon uzimanja lijeka Rubraca, nemojte uzeti dodatnu dozu.
Breast-feeding (see section 4.6)
Dojenje (vidjeti dio 4.6).
The tumour histology was high grade serous in 91.5% of patients, endometrioid in 2.8% and mixed histology in 4.7%.
Histologija tumora bila je serozni tip visokog gradusa u 91,5 % bolesnica, endometrioidni u 2,8 % bolesnica i miješane histologije u 4,7 %.
• medicines used to treat uncontrolled movement or mental disorders - such as pimozide
• lijekove koji se koriste za liječenje nekontroliranih pokreta ili mentalnih poremećaja - kao što je pimozid
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).
Povišene vrijednosti AST/ALT-a 1. - 3. stupnja mogu se zbrinjavati bez promjene doze rukapariba ili modifikacijom liječenja (prekid i/ili smanjenje doze).
Hypercholesterolaemiab, Dehydration
Često hiperkolesterolemijab, dehidracija
Rubraca is an anti-cancer medicine, also known as a ‘PARP (poly adenosine diphosphate-ribose polymerase) inhibitor'.
Rubraca je lijek protiv raka, također poznat kao „PARP inhibitor (inhibitor poli adenozin difosfat-riboza polimeraze)”.
Thrombocytopenia and anaemia led to discontinuation in 1.8% and 2.1% of patients.
Trombocitopenija i anemija dovele su do prestanka primjene u 1,8 % i 2,1 % bolesnica.
Elevations in serum creatinine
Povišene vrijednosti kreatinina u serumu
Rubraca may affect your ability to drive or use tools or machines.
Rubraca može utjecati na Vašu sposobnost upravljanja vozilima ili rada s alatima i strojevima.
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.
U podskupini od 79 bolesnica osjetljivih na platinu interval bez progresije nakon posljednje doze platine bio je ≥ 6 - 12 mjeseci za 55 (69,6 %) bolesnica i > 12 mjeseci za 24 (30,4 %) bolesnice.
Rucaparib also marginally inhibits P-gp in the gut.
Rukaparib također marginalno inhibira P-gp u crijevima.
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.
Bol u abdomenu (što obuhvaća bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena) prijavljen je u 40,1 % bolesnica liječenih rukaparibom, no bio je i vrlo čest (33 %) u bolesnica koje su primale placebo, te je vjerojatno povezan s postojećom bolesti.
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.
Povišene vrijednosti kreatinina u serumu, pretežno blage do umjerene (CTCAE 1. ili 2. stupnja), opažene su u 20 % bolesnica unutar prvih nekoliko tjedana liječenja rukaparibom.
Thus, the risk for clinically significant QTcF increase from baseline (i.e. > 20 msec) is low.
Stoga je rizik za klinički značajno povećanje QTcF u odnosu na početnu vrijednost (tj. > 20 msec) nizak.
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).
U ispitivanjima reproduktivnosti životinja, primjena rukapariba gravidnim ženkama štakora tijekom organogeneze, uzrokovala je embrio-fetalnu toksičnost pri izloženosti manjoj od one kod bolesnica koje su priprimale preporučenu dozu za ljude od 600 mg dvaput dnevno (vidjeti dio 5.3).
Rucaparib accounted for 44.9% and 94.9% of radioactivity in urine and faeces, respectively; while M324 accounted for 50.0% and 5.1% of radioactivity in urine and faeces, respectively.
Rukaparib je bio odgovoran za 44,9 % i 94,9 % radioaktivnosti u urinu odnosno u fecesu, dok je M324 bio odgovoran za 50,0 % i 5,1 % radioaktivnosti u urinu odnosno u fecesu.
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.
U bolesnika s rakom, nakon obroka s visokim sadržajem masti, Cmax povećao se za 20 %, AUC0-24h povećao se za 38 %, a Tmax je bio odgođen za 2,5 sati, u usporedbi s doziranjem u uvjetima na tašte.
The clinical relevance MRP2 and MRP3 interaction in the gut is not known.
Klinički značaj interakcije MRP2 i MRP3 u crijevima nije poznat.
If you take more tablets than you should, tell your doctor, pharmacist or nurse straight away.
Ako uzmete više tableta nego što ste trebali, odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
The primary tumour in most patients was ovarian (84%); most patients (95%) had serous histology and 4% of patients reported endometrioid histology.
Primarni tumor u većine bolesnica bio je rak jajnika (84 %); većina bolesnica (95 %) imala je seroznu histologiju (95 %), a 4 % bolesnica imalo je endometrioidnu histologiju.
Gastrointestinal toxicities
Gastrointestinalne toksičnosti
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.
Nakon primjene jedne oralne doze [14C]-rukapariba kod bolesnika sa solidnim tumorima nepromijenjeni rukaparib bio je odgovoran za 64,0 % radioaktivnosti u plazmi.
Pregnancy/contraception
Trudnoća/kontracepcija
Photosensitivity has been observed in patients treated with rucaparib.
Fotoosjetljivost je uočena u bolesnica liječenih rukaparibom.
Caution when driving or using machines is advised for patients who report fatigue, nausea, or dizziness during treatment with Rubraca (see section 4.8).
Savjetuje se oprez kod upravljanja vozilima ili rada sa strojevima bolesnicama koje prijave umor, mučninu ili vrtoglavicu tijekom liječenja lijekom Rubraca (vidjeti dio 4.8).
Vomiting and nausea were reported in 42% and 77% of patients, respectively and were generally low grade (CTCAE Grade 1 to 3).
Povraćanje i/ili mučnina prijavljeni su u 42 % odnosno 77 % bolesnica i uglavnom su bili niskog stupnja (CTCAE 1. do 3. stupanj).
The majority of adverse reactions were mild to moderate (Grade 1 or 2).
Većina nuspojava bile su blage do umjerene (1. ili 2. stupanj).
• If you forget to take a dose, skip the missed dose.
• Ako ste zaboravili uzeti dozu, preskočite propuštenu dozu.
Patients should be advised to use effective contraception during treatment and for 6 months following the last dose of rucaparib.
Bolesnice treba savjetovati da koriste učinkovitu kontracepciju tijekom liječenja i 6 mjeseci nakon posljednje doze lijeka rukaparib.
Photosensitivity was reported in 13% of patients as low grade skin reactions (CTCAE Grade 1 or 2), and by 2 (0.2%) patients as ≥ CTCAE Grade 3 reaction.
Fotoosjetljivost je prijavljena u 13 % bolesnica kao kožna reakcija niskog stupnja (CTCAE 1. ili 2. stupanj) te u 2 (0,2 %) bolesnica kao reakcija ≥ CTCAE 3. stupanj.
All 106 patients received rucaparib 600 mg twice daily.
Svih 106 bolesnica dobivalo je rukaparib 600 mg dva puta dnevno.
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.
Sve bolesnice primile su barem dvije prethodne kemoterapije na bazi platine (raspon: od 2 do 6), a 28 % bolesnica primilo je barem tri prethodne kemoterapije na bazi platine.
Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised.
Savjetuje se napraviti kompletnu krvnu sliku prije početka liječenja lijekom Rubraca i jednom mjesečno nakon toga.
In an embryo-foetal development study in rats, rucaparib was associated with post-implantation loss at exposures of approximately 0.04 times the human AUC at the recommended dose.
U embrionalno-fetalnom razvojnom ispitivanju na štakorima, rukaparib se povezivao s postimplantacijskim gubitkom pri izloženostima od otprilike 0,04 puta AUC-a u ljudi pri preporučenoj dozi.
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%.
Za populaciju s rakom otpornim na platinu (N=20), ORR prema ocjeni ispitivača bio je 35,0 % (95 % CI [15,4, 59,2], sa stopom potpunog odgovora od 5,0 % i stopom djelomičnog odgovora od 30,0 %.
For the maintenance treatment, patients should start the maintenance treatment with Rubraca no later than 8 weeks after completion of their final dose of the platinum containing regimen.
Kod terapije održavanja bolesnice trebaju započeti s terapijom održavanja lijekom Rubraca najkasnije 8 tjedana nakon primitka posljednje doze režima koji sadrži platinu.
HR (95% CI) p-valueb
HR (95 %-tni CI) p-vrijednostb
• abnormal blood tests - increase in levels of liver enzymes
• abnormalni rezultati krvnih pretraga - povišene razine jetrenih enzima
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).
Izloženosti rukaparibu u plazmi, mjereno s Cmax i AUC-om, bile su otprilike proporcionalne dozi za doze koje su se ispitivale (40 do 500 mg dnevno, 240 do 840 mg dva puta dnevno).
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).
MDS/AML su ozbiljne nuspojave koje se javljaju manje često (0,5 %) u bolesnica na liječenju i tijekom 28 dana sigurnosnog praćenja te često (1,3 %) za sve bolesnice uključujući tijekom dugoročnog sigurnosnog praćenja (stopa se računa na temelju ukupne populacije za ocjenu sigurnosti koja obuhvaćala 1321 bolesnicu izloženu najmanje jednoj dozi oralnog rukapariba u svim kliničkim ispitivanjima).
• fever or infection - these may be signs of a low white blood cell count (neutropenia)
• vrućica ili infekcija - to mogu biti znakovi niskog broja leukocita (neutropenija)