FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately a quarter of placebo-treated patients in the BRCA-mutated subgroup (14/62; 22.6%) received a subsequent PARP inhibitor.
Croatian: Približno jedna četvrtina bolesnica koje su uzimale placebo iz podskupine bolesnica s mutacijom BRCA gena (14/62; 22,6%) naknadno je primila inhibitor PARP-a.
English: If you feel dizzy, weak or tired while taking Lynparza, do not drive or use tools or machines.
Croatian: Ako tijekom liječenja lijekom Lynparza primijetite omaglicu, slabost ili umor, nemojte upravljati vozilom, rukovati alatom niti raditi sa strojevima.
English: Large rearrangements in the BRCA1/2 genes were detected in 5.5% (21/383) of the randomised patients.
Croatian: Velika preslagivanja u genima BRCA1/2 utvrđena su kod 5,5% (21/383) randomiziranih bolesnica.
English: Film-coated tablets Multipack: 112 (2 packs of 56) film-coated tablets
Croatian: Filmom obložene tablete Višestruko pakiranje: 112 (2 pakiranja od 56) filmom obloženih tableta
English: Lynparza can be administered in patients with mild renal impairment (creatinine clearance 51 to 80 ml/min) with no dose adjustment.
Croatian: Lynparza se može davati bolesnicima s blagim oštećenjem bubrežne funkcije (klirens kreatinina 51 do 80 ml/min) bez prilagodbe doze.
English: • You should not take Lynparza if you are pregnant or might become pregnant.
Croatian: • Ne smijete uzimati lijek Lynparza ako ste trudni ili biste mogli zatrudnjeti, jer on može naškoditi nerođenu djetetu.
English: Embryofoetal toxicity
Croatian: Embriofetalna toksičnost
English: • glibenclamide, metformin, repaglinide - used to treat diabetes
Croatian: • glibenklamid, metformin, repaglinid - koriste se za liječenje šećerne bolesti
English: • fentanyl - used to treat cancer pain
Croatian: • fentanil - koristi se za liječenje boli kod raka
English: After a number of rounds of replication, genomic instability can reach insupportable levels and result in cancer cell death, as cancer cells have a high DNA damage load relative to normal cells.
Croatian: Nakon nekoliko replikacijskih ciklusa, genomska nestabilnost može poprimiti neodržive razmjere i dovesti do smrti karcinomske stanice, jer su karcinomske stanice visoko opterećene oštećenjem DNK u odnosu na normalne stanice.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i foliji blistera iza oznake „EXP“.
English: Among the patients entering the trial with measurable disease (target lesions at baseline), an objective response rate of 41% was achieved in the Lynparza arm versus 17% on placebo.
Croatian: Među bolesnicama koje su ušle u ispitivanje s mjerljivom bolešću (ciljne lezije na početku ispitivanja), u skupini liječenoj lijekom Lynparza postignuta je stopa objektivnog odgovora od 41% naspram 17% u skupini koja je primala placebo.
English: TSST- an approximation of PFS2 (DCO 09 May
Croatian: TSST- približna vrijednost PFS2 (završni datum prikupljanja podataka: 9. svibnja
English: In the event that a patient already receiving Lynparza requires treatment with a strong or moderate CYP3A inducer, the prescriber should be aware that the efficacy of Lynparza may be substantially reduced (see section 4.5).
Croatian: U slučaju da je bolesnici koja već prima lijek Lynparza potrebno liječenje snažnim ili umjerenim induktorom CYP3A, propisivač mora biti svjestan da djelotvornost lijeka Lynparza može biti značajno smanjena (vidjeti dio 4.5).
English: OS analysis in patients with no prior chemotherapy for metastatic breast cancer indicated benefit in these patients with a HR of 0.45 (95% CI 0.27-0.77), while for further lines of therapy HR exceeded 1.
Croatian: Analiza OS-a kod bolesnika koji prethodno nisu primali kemoterapiju za metastatski rak dojke ukazala je na korisne učinke kod tih bolesnika, pri čemu je HR iznosio 0,45 (95% CI: 0,27 - 0,77), dok je za sljedeće terapijske linije HR bio veći od 1.
English: Other special populations Limited safety data are available in elderly (age  75 years) and non-Caucasian patients.
Croatian: Dostupni su ograničeni podaci o sigurnosti primjene kod starijih bolesnika (u dobi od  75 godina) i bolesnika koji nisu bijele rase.
English: Patients with HR+ (ER and/or PgR positive) tumours must have received and progressed on at least one endocrine therapy (adjuvant or metastatic) or had disease that the treating physician believed to be inappropriate for endocrine therapy.
Croatian: Bolesnici s HR+ (ER i/ili PgR pozitivnim) tumorom morali su prethodno primiti najmanje jednu endokrinu terapiju (u sklopu adjuvantnog liječenja ili liječenja metastatske bolesti) i doživjeti progresiju bolesti tijekom te terapije ili biti nepogodni za endokrinu terapiju prema ocjeni nadležnog liječnika.
English: All patients comprises of the following subgroups: BRCA1/2-mutated, BRCA1/2 wt/VUS and BRCA1/2 status unknown (11 patients with status unknown, not shown as a separate subgroup in table).
Croatian: Skupina sve bolesnice se sastoji od sljedećih podskupina: bolesnice s mutacijom BRCA1/2 gena, bolesnice s BRCA1/2 wt/VUS i bolesnice s nepoznatim BRCA1/2 statusom (11 bolesnica kojima nije poznat status, nisu prikazane kao posebna podskupina u tablici).
English: Secondary efficacy endpoints included OS, disease control rate (DCR) defined as confirmed CR/PR + SD (stable disease), HRQoL and disease related symptoms.
Croatian: Sekundarne mjere ishoda za djelotvornost uključivale su OS, stopu kontrole bolesti (engl. disease control rate, DCR), koja se definirala kao potvrđen CR/PR + SB (stabilna bolest), HRQoL i simptome povezane s bolešću.
English: Of patients treated with Lynparza, who entered the study with evidence of disease (target or non-target lesions at baseline), 15.0% experienced complete response compared with 9.1% of patients on placebo.
Croatian: Među bolesnicama liječenima lijekom Lynparza koje su ušle u ispitivanje s dokazima bolesti (ciljne ili druge lezije na početku ispitivanja), potpun odgovor postiglo je njih 15,0%, dok je isto zabilježeno u 9,1% bolesnica koje su primale placebo.
English: Ovarian cancer was the primary tumour in 86% of the patients.
Croatian: Karcinom jajnika bio je primarni tumor u 86% bolesnica.
English: Date of first authorisation: 16 December 2014 Date of last renewal:
Croatian: Datum prvog odobrenja: 16. prosinca 2014.
English: In a female fertility study where rats were dosed until implantation, although extended oestrus was observed in some animals, mating performance and pregnancy rate was not affected.
Croatian: U istraživanju plodnosti ženki štakora, u kojem se lijek primjenjivao do implantacije, nije bilo utjecaja na sposobnost parenja i stopu graviditeta unatoč tomu što je kod nekih životinja primijećeno produljenje estrusnih ciklusa.
English: Dose adjustments for co-administration with CYP3A inhibitors Concomitant use of strong or moderate CYP3A inhibitors is not recommended and alternative agents should be considered.
Croatian: Prilagodba doze zbog istodobne primjene inhibitora CYP3A Ne preporučuje se istodobna primjena snažnih ili umjerenih inhibitora CYP3A te je potrebno razmotriti primjenu zamjenskih lijekova.
English: One pack contains 448 capsules (4 bottles of 112 capsules).
Croatian: Jedno pakiranje sadrži 448 kapsula (4 boce sa 112 kapsula).
English: Response to prior platinum chemotherapy was complete in 45% and partial in 55% of the patients.
Croatian: Odgovor na prethodnu kemoterapiju platinom bio je potpun u 45% i djelomičan u 55% bolesnica.
English: When olaparib is bound to the active site of DNA-associated PARP it prevents the dissociation of PARP and traps it on the DNA, thus blocking repair.
Croatian: Nakon što se olaparib veže za aktivno mjesto PARP-a spojenog za DNK, on sprječava odvajanje PARP-a i drži ga pričvršćenim za DNK te tako onemogućuje popravak.
English: Tell your doctor, pharmacist or nurse if you are taking any of the above or any other medicines.
Croatian: Recite svom liječniku, ljekarniku ili medicinskoj sestri ako uzimate bilo koji od navedenih lijekova ili neki drugi lijek.
English: Instead, alternative and error-prone pathways are activated, such as the non-homologous end joining (NHEJ) pathway, leading to increased genomic instability.
Croatian: Umjesto toga se aktiviraju drugi putovi kod kojih često dolazi do pogrešaka, poput povezivanja nehomolognih krajeva (engl. non-homologous end joining, NHEJ), što povećava genomsku nestabilnost.
English: On multiple dosing, an AUC accumulation ratio of 1.8 was observed and PK appeared to be time-dependent to a small extent.
Croatian: Nakon primjene višestrukih doza primijećen je omjer kumulacije (AUC) od 1,8 dok je farmakokinetika u maloj mjeri bila ovisna o vremenu.
English: It can be used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
Croatian: Može se koristiti nakon što je rak odgovorio na prethodno liječenje standardnom kemoterapijom utemeljenom na platini.
English: • pimozide, quetiapine - used to treat mental health problems
Croatian: • pimozid, kvetiapin - koriste se za liječenje psihičkih tegoba
English: What Lynparza is used for
Croatian: Za što se Lynparza koristi
English: Following oral administration of olaparib via the tablet formulation (2 x 150 mg), absorption is rapid with median peak plasma concentrations typically achieved 1.5 hours after dosing.
Croatian: Nakon peroralne primjene olapariba u obliku tableta (2 x 150 mg), apsorpcija je brza, a medijan vršnih koncentracija u plazmi obično se postiže 1,5 sati nakon primjene doze.
English: Tests and checks Your doctor will check your blood before and during treatment with Lynparza.
Croatian: Liječnik će provoditi krvne pretrage prije i tijekom liječenja lijekom Lynparza.
English: In first-line ovarian cancer maintenance treatment, patients experienced nausea events (77% on olaparib, 38% on placebo), vomiting (40% on olaparib, 15% on placebo), diarrhoea (34% on olaparib, 25% on placebo) and dyspepsia (17% on olaparib, 12% on placebo).
Croatian: Kod bolesnica koje su primale prvu liniju terapije održavanja za karcinom jajnika zabilježeni su mučnina (77% uz olaparib, 38% uz placebo), povraćanje (40% uz olaparib, 15% uz placebo), proljev (34% uz olaparib, 25% uz placebo) i dispepsija (17% uz olaparib, 12% uz placebo).
English: Proportion of patients event free
Croatian: Udio bolesnica bez događaja
English: In this study 302 patients with a documented deleterious or suspected deleterious gBRCA mutation were randomised 2:1 to receive either Lynparza (300 mg [2 x 150 mg tablets] twice daily) or physician's choice of chemotherapy (capecitabine 42%, eribulin 35%, or vinorelbine 17%) until progression or unacceptable toxicity.
Croatian: U tom su ispitivanju 302 bolesnika s potvrđenom ili suspektnom gBRCA mutacijom randomizirana u omjeru 2:1 za primanje lijeka Lynparza (300 mg [2 tablete od 150 mg] dvaput na dan) ili kemoterapije prema odabiru liječnika (kapecitabin u 42%, eribulin u 35% ili vinorelbin u 17% slučajeva) do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: There are very limited data in patients with a somatic BRCA mutation.
Croatian: Podaci o bolesnicama sa somatskim BRCA mutacijama vrlo su ograničeni.
English: Lynparza is for oral use.
Croatian: Lynparza je namijenjena za peroralnu primjenu.
English: Lynparza monotherapy has been associated with adverse reactions generally of mild or moderate severity (CTCAE grade 1 or 2) and generally not requiring treatment discontinuation.
Croatian: Monoterapija lijekom Lynparza povezuje se s nuspojavama uglavnom blage ili umjerene težine (1. ili 2. stupnja prema CTCAE kriterijima), koje u načelu ne zahtijevaju prekid liječenja.
English: Number of patients at risk Olaparib 300 mg twice daily tablet
Croatian: Broj bolesnika pod rizikom Olaparib 300 mg dvaput na dan (tablete)
English: Genetic counselling for patients with BRCA1/2 mutations should be performed according to local regulations.
Croatian: Genetičko savjetovanje za bolesnice s mutacijama gena BRCA1/2 treba biti provedeno prema lokalnim propisima.
English: Patient-reported outcome (PRO) data indicate no difference for the olaparib-treated patients as compared to placebo as measured by improvement and worsening rates in the TOI and FACT-O total.
Croatian: Patient-reported outcome, PRO) pokazuju da nema razlike između bolesnica liječenih olaparibom u usporedbi sa placebom, što je ocjenjivano stopama poboljšanja i pogoršanja indeksa TOI i FACT-O.
English: Appropriate clinical monitoring is recommended for patients receiving CYP3A substrates with a narrow therapeutic margin concomitantly with olaparib.
Croatian: Preporučuje se odgovarajuće kliničko praćenje bolesnika u kojih se olaparib primjenjuje istodobno sa supstratima CYP3A s uskim terapijskim rasponom.
English: All patients had potential contributing factors for the development of MDS/AML, having received previous chemotherapy with platinum agents.
Croatian: Svi su bolesnici imali faktore koji su mogli pridonijeti razvoju MDS-a/AML-a, jer su prethodno primali kemoterapiju lijekovima koji sadrže platinu.
English: The pharmacokinetics of olaparib at the 300 mg tablet dose are characterised by an apparent plasma clearance of ~7 L/h, an apparent volume of distribution of ~158 L and a terminal half-life of 15 hours.
Croatian: Farmakokinetiku olapariba u obliku tableta u dozi od 300 mg karakteriziraju prividan plazmatski klirens od ~7 l/h, prividan volumen distribucije od ~158 l i terminalni poluvijek od 15 sati.
English: Table 1 Tabulated list of adverse reactions
Croatian: Tablica 1 Tablični sažetak nuspojava
English: The analysis was performed using a Cox proportional hazards model including response to previous platinum chemotherapy (CR or PR) as a covariate.
Croatian: Analiza je provedena uz primjenu Coxova modela proporcionalnih hazarda, u kojem je kovarijanta bila odgovor na prethodnu kemoterapiju platinom (CR ili PR).
English: If pneumonitis is confirmed, Lynparza treatment should be discontinued and the patient treated appropriately.
Croatian: Potvrdi li se pneumonitis, liječenje lijekom Lynparza treba obustaviti, a bolesnika primjereno liječiti.
English: Pack of 448 capsules (4 bottles of 112 capsules).
Croatian: Pakiranje od 448 kapsula (4 boce sa 112 kapsula).
English: • cyclosporine, sirolimus, tacrolimus - used to suppress the immune system
Croatian: • ciklosporin, sirolimus, takrolimus - koriste se za supresiju imunološkog sustava
English: Lynparza can be administered to patients with mild or moderate hepatic impairment (Child-Pugh classification A or B) with no dose adjustment (see section 5.2).
Croatian: Lynparza se može davati bolesnicima s blagim ili umjerenim oštećenjem jetrene funkcije (Child-Pugh klasifikacija A ili B) bez prilagodbe doze (vidjeti dio 5.2).
English: In the olaparib arm 8% with measurable disease had a complete response versus 1.5% of patients in the comparator arm; 74/167 (44%) of patients in the olaparib arm had a partial response versus 14/66 (21%) of patients in the chemotherapy arm.
Croatian: U skupini liječenoj olaparibom potpuni je odgovor imalo 8% bolesnika s mjerljivom bolešću naspram 1,5% bolesnika u usporednoj skupini, dok je djelomičan odgovor imalo 74/167 (44%) bolesnika u skupini liječenoj olaparibom naspram 14/66 (21%) bolesnika u skupini koja je primala kemoterapiju.
English: The safety and efficacy of olaparib in patients with gBRCA1/2-mutations who had HER2-negative metastatic breast cancer were studied in a Phase III randomised, open-label, controlled trial (OlympiAD).
Croatian: Sigurnost i djelotvornost olapariba kod bolesnika s gBRCA1/2 mutacijama i HER2-negativnim metastatskim rakom dojke ispitivale su se u randomiziranom, otvorenom, kontroliranom ispitivanju faze III (OlympiAD).
English: Response to prior platinum chemotherapy was complete in 47% and partial in 53% of the patients.
Croatian: . Odgovor na prethodnu kemoterapiju platinom bio je potpun u 47% i djelomičan u 53% bolesnica.
English: In this study 391 patients were randomised 2:1 to receive either Lynparza (300 mg [2 x 150 mg tablets] twice daily) or placebo.
Croatian: U tom je ispitivanju 391 bolesnica randomizirana u omjeru 2:1 za primanje lijeka Lynparza (300 mg [2 tablete od 150 mg] dvaput na dan) ili placeba.
English: C-olaparib to female patients, unchanged olaparib accounted for the majority of the circulating radioactivity in plasma (70%) and was the major component found in both urine and faeces (15% and 6% of the dose, respectively).
Croatian: C-olapariba bolesnicama, olaparib je u neizmijenjenu obliku činio glavninu cirkulirajuće radioaktivnosti u plazmi (70%) te je bio glavna komponentna pronađena i u mokraći (15% doze) i u fecesu (6% doze).
English: • The usual recommended dose is 8 capsules (400 mg) taken by mouth twice a day (a total of 16 capsules each day).
Croatian: • Uobičajena preporučena doza je 8 kapsula (400 mg) dvaput na dan kroz usta (ukupno 16
English: The pharmacokinetics of olaparib at the 400 mg twice daily capsule dose are characterised by an apparent plasma clearance of ~8.6 L/h, an apparent volume of distribution of ~167 L and a terminal half-life of 11.9 hours.
Croatian: Farmakokinetiku olapariba u dozi od 400 mg dvaput na dan u obliku kapsula karakteriziraju prividan plazmatski klirens od ~8,6 l/h, prividan volumen distribucije od ~167 l terminalni poluvijek od 11,9 sati.
English: It is used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
Croatian: Koristi se nakon što je rak odgovorio na prethodno liječenje standardnom kemoterapijom utemeljenom na platini.
English: The Grade ≥ 3 adverse reactions occurring in > 2% of patients were anaemia (16%), neutropenia (6%), fatigue/asthenia (6%), leukopenia (3%), thrombocytopenia (2%) and vomiting (2%).
Croatian: Nuspojave ≥ 3. stupnja težine koje su se javile u > 2% bolesnica bile su anemija (16%), neutropenija (6%), umor/astenija (6%), leukopenija (3%), trombocitopenija (2%) i povraćanje (2%).
English: The following adverse reactions have been identified in clinical trials with patients receiving Lynparza monotherapy where patient exposure is known.
Croatian: Sljedeće su nuspojave identificirane u kliničkim ispitivanjima u kojima su sudjelovali bolesnici koji su primali monoterapiju lijekom Lynparza i za koje je poznata izloženost lijeku.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before or during treatment with Lynparza:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije ili tijekom liječenja lijekom Lynparza:
English: In vitro, olaparib inhibits the efflux transporter P-gp (IC50 = 76 µM), therefore it cannot be excluded that olaparib may cause clinically relevant drug interactions with substrates of P-gp (e.g. simvastatin, pravastatin, dabigatran, digoxin and colchicine).
Croatian: In vitro, olaparib inhibira efluksni prijenosnik P-gp (IC50 = 76 µM), stoga se ne može isključiti mogućnost da olaparib može uzrokovati klinički značajne interakcije sa supstratima P-gp-a (npr. simvastatin, pravastatin, dabigatran, digoksin i kolhicin).
English: -----olaparib 400 mg bd twice daily, ____placebo, x-axis=time from randomisation in months, yaxis=OS (overall survival), n-olaparib= number of patients at risk-olaparib, n-placebo=number of patients at risk-placebo
Croatian: -----olaparib 400 mg dvaput na dan, ____placebo, x-os=vrijeme od randomizacije u mjesecima, y-os= OS (ukupno preživljenje), n-olaparib= broj bolesnika pod rizikom-olaparib, n-placebo=broj bolesnika pod rizikom-placebo
English: A clinical study to evaluate the impact of rifampicin, a known CYP3A inducer, has shown that co-administration with olaparib decreased olaparib mean Cmax by 71% (90% CI: 76-67%) and mean AUC by 87% (90% CI: 89-84%).
Croatian: Kliničko ispitivanje za ocjenu učinka rifampicina, poznatog induktora CYP3A, pokazalo je da je istodobna primjena s olaparibom smanjila srednju vrijednost Cmax olapariba za 71% (90% CI: 76 - 67%) i srednju vrijednost AUC za 87% (90% CI: 89 - 84%).
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of olaparib in paediatric patients.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja kojima bi se ocijenila farmakokinetika olapariba u pedijatrijskih bolesnika.
English: In vitro, olaparib inhibits the efflux transporter P-gp (IC50 = 76µM), therefore it cannot be excluded that olaparib may cause clinically relevant drug interactions with substrates of P-gp (e.g. simvastatin, pravastatin, dabigatran, digoxin and colchicine).
Croatian: In vitro, olaparib inhibira efluksni prijenosnik P-gp (IC50 = 76µM), stoga se ne može isključiti mogućnost da olaparib može uzrokovati klinički značajne interakcije sa supstratima P-gp-a (npr. simvastatin, pravastatin, dabigatran, digoksin, i kolhicin).
English: Only PSR patients with partially platinum-sensitive disease (platinum-free interval of 6 to 12 months) and patients with platinum-sensitive disease (platinum-free interval of >12 months) who were in response following completion of last platinum-based chemotherapy were enrolled.
Croatian: U ispitivanje su bile uključene samo bolesnice s recidivom karcinoma djelomično osjetljivog na platinu ( interval bez platine od 6 do 12 mjeseci) i bolesnice s recidivom karcinoma osjetljivog na platinu (interval bez platine > 12 mjeseci) koje su ostvarile odgovor nakon završetka posljednje kemoterapije utemeljene na platini.
English: Lynparza co-administration with strong or moderate CYP3A inhibitors is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena lijeka Lynparza sa snažnim ili umjerenim inhibitorima CYP3A (vidjeti dio 4.5).
English: In replicating cells this also leads to the formation of DNA double-strand breaks (DSBs) when replication forks meet the PARP-DNA adducts.
Croatian: U replicirajućim stanicama to uzrokuje i nastanak dvolančanih lomova DNK (engl. double-strand braks, DSB) kada replikacijske vilice naiđu na PARP-DNK adukte.
English: • cisapride - used to treat stomach problems
Croatian: • cisaprid - koristi se za liječenje želučanih tegoba
English: In BRCA-deficient in vivo models, olaparib given after platinum treatment resulted in a delay in tumour progression and an increase in overall survival compared to platinum treatment alone.
Croatian: U in vivo modelima s deficijentnim BRCA genom, olaparib primijenjen nakon liječenja platinom usporio je progresiju tumora i produljio ukupno preživljenje u usporedbi s liječenjem samo platinom.
English: For patients with platinum sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, it is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity.
Croatian: Kod bolesnica s recidivom na platinu osjetljivog epitelnog karcinoma jajnika visokog stupnja nediferenciranosti, karcinoma jajovoda ili primarnog peritonealnog karcinoma preporučuje se nastaviti liječenje do progresije osnovne bolesti ili pojave neprihvatljive toksičnosti.
English: Uncommon Hypersensitivity a, Dermatitis
Croatian: Poremećaji imunološkog sustava često osip manje često preosjetljivost a, dermatitis
English: In Study 19, the incidence of anaemia was 22.8% (CTCAE grade ≥3 7.4%) and the incidences of dose interruptions, reductions and discontinuations for anaemia were 2.9%, 5.1% and 0%, respectively; 16.2% of patients treated with olaparib needed one or more blood transfusions during the treatment.
Croatian: U ispitivanju 19, incidencija anemije je bila 22,8% (CTCAE stupanj ≥ 3 u 7,4%), a incidencija privremenog prekida doziranja je bila 2,9%, smanjenja doze zbog anemije 5,1%, a trajnog prekida terapije 0%; 16,2% bolesnica liječenih olaparibom trebalo je jednu ili više transfuzija krvi tijekom liječenja.
English: • You should have a pregnancy test before starting Lynparza, at regular times during treatment and 1 month after taking the last dose of Lynparza.
Croatian: • Morate napraviti test na trudnoću prije početka liječenja lijekom Lynparza, redovito za vrijeme trajanja liječenja te 1 mjesec nakon što uzmete posljednju dozu lijeka Lynparza.