FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient.
Croatian: Povišene vrijednosti jetrenih transaminaza (aspartat aminotransferaze (AST) i/ili alanin aminotransferaze (ALT)) javljaju se ranije tijekom liječenja i uglavnom su prolazne.
English: 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
Croatian: 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
English: Increased alanine aminotransferase, Increased aspartate aminotransferase
Croatian: Često povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze
English: Haematological adverse reactions of all CTCAE Grades of anaemia, thrombocytopenia and neutropenia were reported in 42%, 26% and 16% of patients respectively.
Croatian: Hematološke nuspojave svih CTCAE stupnjeva anemije, trombocitopenije i neutropenije prijavljene su u 42 %, 26 % i 16 % bolesnika.
English: Rucaparib preferentially distributed to red blood cells with a blood-to-plasma concentration ratio of 1.83.
Croatian: Rukaparib se preferencijalno distribuira u eritrocite s omjerom koncentracije krvplazma od 1,83.
English: The findings in non-clinical toxicology studies performed with oral rucaparib were generally consistent with the adverse events observed in clinical studies.
Croatian: Rezultati nekliničkih toksikoloških ispitivanja provedenih s oralnim rukaparibom bili su uglavnom dosljedni štetnim događajima opaženim u kliničkim ispitivanjima.
English: IRR- assessment for the ITT population supported the primary endpoint.
Croatian: Independent radiology review) za ITT populaciju podupirala je primarni ishod.
English: • If you are sick (vomit) after taking Rubraca, do not take an extra dose.
Croatian: • Ako povraćate nakon uzimanja lijeka Rubraca, nemojte uzeti dodatnu dozu.
English: Breast-feeding (see section 4.6)
Croatian: Dojenje (vidjeti dio 4.6).
English: The tumour histology was high grade serous in 91.5% of patients, endometrioid in 2.8% and mixed histology in 4.7%.
Croatian: Histologija tumora bila je serozni tip visokog gradusa u 91,5 % bolesnica, endometrioidni u 2,8 % bolesnica i miješane histologije u 4,7 %.
English: • medicines used to treat uncontrolled movement or mental disorders - such as pimozide
Croatian: • lijekove koji se koriste za liječenje nekontroliranih pokreta ili mentalnih poremećaja - kao što je pimozid
English: 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).
Croatian: Povišene vrijednosti AST/ALT-a 1. - 3. stupnja mogu se zbrinjavati bez promjene doze rukapariba ili modifikacijom liječenja (prekid i/ili smanjenje doze).
English: Hypercholesterolaemiab, Dehydration
Croatian: Često hiperkolesterolemijab, dehidracija
English: Rubraca is an anti-cancer medicine, also known as a ‘PARP (poly adenosine diphosphate-ribose polymerase) inhibitor'.
Croatian: Rubraca je lijek protiv raka, također poznat kao „PARP inhibitor (inhibitor poli adenozin difosfat-riboza polimeraze)”.
English: Thrombocytopenia and anaemia led to discontinuation in 1.8% and 2.1% of patients.
Croatian: Trombocitopenija i anemija dovele su do prestanka primjene u 1,8 % i 2,1 % bolesnica.
English: Elevations in serum creatinine
Croatian: Povišene vrijednosti kreatinina u serumu
English: Rubraca may affect your ability to drive or use tools or machines.
Croatian: Rubraca može utjecati na Vašu sposobnost upravljanja vozilima ili rada s alatima i strojevima.
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.
Croatian: 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.
English: Rucaparib also marginally inhibits P-gp in the gut.
Croatian: Rukaparib također marginalno inhibira P-gp u crijevima.
English: Abdominal pain (combined terms abdominal pain, abdominal pain lower, abdominal pain upper) was reported in 40.1% of rucaparib treated patients, but was also very common (33%) in placebo patients, most likely associated with underlying disease.
Croatian: 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.
English: Increases in serum creatinine, predominantly mild to moderate (CTCAE Grade 1 or 2), were observed in 20% of patients within the first few weeks of treatment with rucaparib.
Croatian: 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.
English: Thus, the risk for clinically significant QTcF increase from baseline (i.e. > 20 msec) is low.
Croatian: Stoga je rizik za klinički značajno povećanje QTcF u odnosu na početnu vrijednost (tj. > 20 msec) nizak.
English: In an animal reproduction study, administration of rucaparib to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see section 5.3).
Croatian: 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).
English: 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.
Croatian: 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.
English: In patients with cancer following a high-fat meal, the Cmax increased by 20%, the AUC0-24h increased by 38%, and the Tmax was delayed by 2.5 hours, as compared with dosing under fasted conditions.
Croatian: 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.
English: The clinical relevance MRP2 and MRP3 interaction in the gut is not known.
Croatian: Klinički značaj interakcije MRP2 i MRP3 u crijevima nije poznat.
English: If you take more tablets than you should, tell your doctor, pharmacist or nurse straight away.
Croatian: Ako uzmete više tableta nego što ste trebali, odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
English: The primary tumour in most patients was ovarian (84%); most patients (95%) had serous histology and 4% of patients reported endometrioid histology.
Croatian: 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.
English: Gastrointestinal toxicities
Croatian: Gastrointestinalne toksičnosti
English: 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.
Croatian: Nakon primjene jedne oralne doze [14C]-rukapariba kod bolesnika sa solidnim tumorima nepromijenjeni rukaparib bio je odgovoran za 64,0 % radioaktivnosti u plazmi.
English: Pregnancy/contraception
Croatian: Trudnoća/kontracepcija
English: Photosensitivity has been observed in patients treated with rucaparib.
Croatian: Fotoosjetljivost je uočena u bolesnica liječenih rukaparibom.
English: Caution when driving or using machines is advised for patients who report fatigue, nausea, or dizziness during treatment with Rubraca (see section 4.8).
Croatian: 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).
English: Vomiting and nausea were reported in 42% and 77% of patients, respectively and were generally low grade (CTCAE Grade 1 to 3).
Croatian: Povraćanje i/ili mučnina prijavljeni su u 42 % odnosno 77 % bolesnica i uglavnom su bili niskog stupnja (CTCAE 1. do 3. stupanj).
English: The majority of adverse reactions were mild to moderate (Grade 1 or 2).
Croatian: Većina nuspojava bile su blage do umjerene (1. ili 2. stupanj).
English: • If you forget to take a dose, skip the missed dose.
Croatian: • Ako ste zaboravili uzeti dozu, preskočite propuštenu dozu.
English: Patients should be advised to use effective contraception during treatment and for 6 months following the last dose of rucaparib.
Croatian: Bolesnice treba savjetovati da koriste učinkovitu kontracepciju tijekom liječenja i 6 mjeseci nakon posljednje doze lijeka rukaparib.
English: 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.
Croatian: 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.
English: All 106 patients received rucaparib 600 mg twice daily.
Croatian: Svih 106 bolesnica dobivalo je rukaparib 600 mg dva puta dnevno.
English: 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.
Croatian: 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.
English: Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised.
Croatian: Savjetuje se napraviti kompletnu krvnu sliku prije početka liječenja lijekom Rubraca i jednom mjesečno nakon toga.
English: 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.
Croatian: 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.
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%.
Croatian: 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 %.
English: 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.
Croatian: Kod terapije održavanja bolesnice trebaju započeti s terapijom održavanja lijekom Rubraca najkasnije 8 tjedana nakon primitka posljednje doze režima koji sadrži platinu.
English: HR (95% CI) p-valueb
Croatian: HR (95 %-tni CI) p-vrijednostb
English: • abnormal blood tests - increase in levels of liver enzymes
Croatian: • abnormalni rezultati krvnih pretraga - povišene razine jetrenih enzima
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).
Croatian: 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).
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).
Croatian: 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).
English: • fever or infection - these may be signs of a low white blood cell count (neutropenia)
Croatian: • vrućica ili infekcija - to mogu biti znakovi niskog broja leukocita (neutropenija)
English: • medicines which suppress the immune system - such as ciclosporin, sirolimus or tacrolimus
Croatian: • lijekove koji potiskuju imunološki sustav - kao što je ciklosporin, sirolimus ili takrolimus
English: The median progression-free survival was 162 days (95% CI [51-223]).
Croatian: Medijan preživljenja bez progresije bio je 162 dana (95 % IP [51-223]).
English: Based on the animal studies, impact on fertility associated with the use of rucaparib cannot be ruled out (see section 5.3).
Croatian: Rezultati iz ispitivanja na životinjama pokazali su da se utjecaj na plodonost povezan s primjenom rukapariba ne može isključiti. (vidjeti dio 5.3).
English: The progression-free interval to penultimate platinum therapy was 6-12 months in 39% of patients and > 12 months in 61%.
Croatian: Interval bez progresije bolesti za pretposljednju terapiju platinom iznosio je 6 - 12 mjeseci u 39 % bolesnica te > 12 mjeseci u 61 % njih.
English: Rubraca can be administered with or without food.
Croatian: Rubraca se može primjenjivati sa ili bez hrane.
English: What you need to know before you take Rubraca Do not take Rubraca:
Croatian: Što morate znati prije nego počnete uzimati lijek Rubraca Nemojte uzimati lijek Rubraca:
English: • abnormal blood tests - increase in blood creatinine levels
Croatian: • abnormalni rezultati krvnih pretraga - povišene razine kreatinina u krvi
English: In a population PK analysis, no clinically relevant PK differences were observed among patients with different CYP2D6 phenotypes (including poor metabolizers, n=9; intermediate metabolizers, n=71; normal metabolizers, n=76; and ultra-rapid metabolizers, n=4) or patients with different CYP1A2 phenotypes (including normal metabolizers, n=28; hyperinducers, n=136).
Croatian: U populacijskoj PK analizi nisu uočene klinički relevantne PK razlike među bolesnicama s različitim CYP2D6 fenotipovima. (uključujući slabe metabolizatore, n=9; intermedijarne metabolizatore, n=71; normalne metabolizatore, n=76; i vrlo brze metabolizatore, n=4) ili pacijente s različitim CYP1A2 fenotipovima (uključujući normalne metabolizatore, n=28; hiperinduktore, n=136).
English: Recommended dose adjustments Dose reduction
Croatian: Preporučene prilagodbe doze Smanjenje doze
English: • medicines used to relax muscles - such as tizanidine
Croatian: • lijekove koji se koriste za opuštanje mišića - kao što je tizanidin
English: • medicines to lower blood sugar levels and treat diabetes - such as metformin
Croatian: • lijekove za smanjenje razina šećera u krvi i za liječenje dijabetesa - kao što je metformin
English: Enzymes responsible for rucaparib metabolism have not been identified.
Croatian: Nisu identificirani enzimi koji su odgovorni za metabolizam rukapariba.
English: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib.
Croatian: Mijelodisplastični sindrom/akutna mijeloična leukemija Mijelodisplastični sindrom/akutna mijeloična leukemija (MDS/AML), uključujući slučajeve sa smrtnim ishodom, prijavljeni su u bolesnica koje su primale rukaparib.
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).
Croatian: Analiza odnosa koncentracije i produljenja QTcF provedena je upotrebom podataka od 54 bolesnice sa solidnim tumorom kojima su primjenjivane kontinuirane doze rukapariba u rasponu od 40 mg jednom dnevno do 840 mg dva puta dnevno (1,4 puta više od odobrene preporučene doze).
English: Caution is advised when co-administering medicinal products that are CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine).
Croatian: Potreban je oprez kod istodobne primjene lijekova uskog terapijskog indeksa koji su supstrati CYP3A (npr. alfentanila, astemizola, cisaprida, ciklosporina, dihidroergotamina, ergotamina, fentanila, pimozida, kinidina, sirolimusa, takrolimusa, terfenadina).
English: • being short of breath, feeling tired, having pale skin, or fast heart beat - these may be signs of a low red blood cell count (anaemia)
Croatian: • nedostatak zraka, osjećaj umora, blijeda koža ili ubrzani otkucaji srca - to mogu biti znakovi niskog broja eritrocita (anemija)
English: No dose adjustment is considered necessary for co-administered medicinal products that are CYP2C19 substrates.
Croatian: Smatra se da nije potrebna prilagodba doze za istodobno primjenjivane lijekove koji su supstrati CYP2C19.
English: At clinical exposures, rucaparib did not inhibit bile salt export pump (BSEP), OATP1B1, OATP1B3, OAT1 and OAT3.
Croatian: Pri kliničkim izloženostima, rukaparib nije inhibirao pumpu za izbacivanje žučnih soli (engl. bile salt export pump, BSEP), OATP1B1, OATP1B3, OAT1 i OAT3.
English: ORR was similar for patients with germline BRCA-mutant ovarian cancer or somatic BRCA-mutant ovarian cancer and for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
Croatian: ORR je bio sličan za bolesnice koje su imale rak jajnika s germinativnim BRCA mutacijama ili somatskim BRCA mutacijama i za bolesnice s mutacijom BRCA1 gena ili mutacijom BRCA2 gena.
English: There are no data on the effect of rucaparib on human fertility.
Croatian: Ne postoje podaci o učinku rukapariba na plodnost kod ljudi.
English: • The active substance is rucaparib.
Croatian: • Djelatna tvar je rukaparib.
English: Adverse reactions may be managed through dose interruptions and/or dose reductions for moderate to severe reactions (i.e. CTCAE Grade 3 or 4) such as neutropenia, anaemia and thrombocytopenia.
Croatian: Nuspojave se mogu zbrinjavati prekidima primjene doza i/ili smanjenjima doza kod umjerenih do teških reakcija (tj. CTCAE 3. ili 4. stupnja) kao što je neutropenija, anemija ili trombocitopenija.
English: • high cholesterol levels
Croatian: • visoke razine kolesterola
English: No cardiac effects were observed with oral dosing of rucaparib in repeat-dose toxicology studies at a rucaparib Cmax comparable to that observed in patients.
Croatian: Nikakvi kardiološki učinci nisu uočeni pri peroralnim dozama rukapariba u toksikološkim ispitivanjima ponovljenih doza pri vrijednosti Cmax rukapariba usporedivoj s onom primjećenom u pacijenata.
English: It is unknown whether rucaparib/or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se rukaparib ili njegovi metaboliti u majčino mlijeko.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving rucaparib.
Croatian: Žene u reproduktivnoj dobi treba savjetovati da izbjegavaju trudnoću dok primaju lijek rukaparib.
English: If you forget to take Rubraca
Croatian: Ako ste zaboravili uzeti lijek Rubraca
English: In vitro, rucaparib was shown to be a substrate of P-gp and BCRP.
Croatian: In vitro, rukaparib se pokazao kao supstrat P-gp i BCRP.
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.
Croatian: Nuspojave koje su dovele do trajnog prestanka primjene pojavile su se u 10 % bolesnika, a trombocitopenija, mučnina, anemija i umor/astenija bile su najčešće nuspojave koje su dovele do trajnog prestanka primjene.
English: • medicines to treat allergic reactions - such as astemizole or terfenadine
Croatian: • lijekove za liječenje alergijskih reakcija - kao što je astemizol ili terfenadin
English: Platinum-sensitive patients had received 2 (n=47, 59.5%), 3 (n=28, 35.4%), or > 3 (n=4, 5.1%) prior lines of platinumbased chemotherapy.
Croatian: Bolesnice s rakom osjetljivim na platinu primile su 2 (n=47; 59,5 %), 3 (n=28; 35,4 %) ili > 3 (n=4; 5,1 %) prethodne linije kemoterapije na bazi platine.
English: Rucaparib has been shown to have in vitro and in vivo anti-tumour activity in BRCA mutant cell lines through a mechanism known as synthetic lethality, whereby the loss of two DNA repair pathways is required for cell death.
Croatian: Pokazalo se da rukaparib in vitro i in vivo ima antitumorsku aktivnost u staničnim linijama s BRCA mutacijama putem mehanizma poznatog kao sintetička smrtnost, u kojima je za smrt stanice potreban gubitak dva puta popravka DNK-a.
English: You may get sunburn more easily during treatment with Rubraca.
Croatian: Možete mnogo lakše dobiti opekline tijekom liječenja lijekom Rubraca.
English: Increased rucaparib-induced cytotoxicity and anti-tumour activity was observed in tumour cell lines with deficiencies in BRCA1/2 and other DNA repair genes.
Croatian: Povećana protutumorska aktivnost i citotoksičnost uzrokovana rukaparibom uočeni su u linijama tumorskih stanica s nedostacima gena BRCA1/2 i drugih gena za popravak DNK.
English: Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the rucaparib and placebo arms.
Croatian: Demografija, karakteristike bolesti na početku ispitivanja i anamneza prethodne terapije općenito su bili dobro uravnoteženi između skupine koja je primala rukaparib i skupine koja je primala placebo.
English: • medicines to treat severe pain - such as alfentanil or fentanyl
Croatian: • lijekove protiv snažnih bolova - kao što je alfentanil ili fentanil
English: This is because it is not known if rucaparib passes into breast milk.
Croatian: To je stoga što nije poznato izlučuje li se rukaparib u majčino mlijeko.
English: Grade 4
Croatian: 4. stupanj
English: 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.
Croatian: Stoga nije ispitana djelotvornost lijeka Rubraca u bolesnica koje su primile prethodnu terapiju inhibitorom PARP-a u okviru terapije održavanja te se ne može ekstrapolirati iz dostupnih podataka.
English: Limited data are available for patients with moderate or severe hepatic impairment (see section 4.2).
Croatian: Dostupni su ograničeni podaci za bolesnice s umjerenim ili teškim oštećenjem funkcije jetre (vidjeti dio 4.2).
English: Because of the potential for serious adverse reactions in breast-fed infants from rucaparib, breast-feeding is contraindicated during treatment with Rubraca and for 2 weeks after the final dose (see section 4.3).
Croatian: Zbog potencijalnih ozbiljnih nuspojava rukapariba kod dojenčadi, dojenje je kontraindicirano tijekom liječenja lijekom Rubraca i 2 tjedna nakon posljednje doze (vidjeti dio 4.3).
English: Fatiguec, Pyrexia
Croatian: Vrlo često umorc, pireksija