natgillin/translations-raw huggingface dataset:
The analysis was performed using a Cox proportional hazards model including response to previous platinum chemotherapy (CR or PR) as a covariate. 
Analiza je bila izvedena s Coxovim modelom sorazmernih ogroženosti, ki je kot sospremenljivko vključeval odziv (CR ali PR) na predhodno kemoterapijo na osnovi platine.
Breast-feeding during treatment and 1 month after the last dose (see section 4.6). 
Dojenje med zdravljenjem in en mesec po zadnjem odmerku (glejte poglavje 4.6).
PARPs are required for the efficient repair of DNA single strand breaks and an important aspect of PARP-induced repair requires that after chromatin modification, PARP auto-modifies itself and dissociates from the DNA to facilitate access for base excision repair (BER) enzymes. 
Pomemben vidik poprave s PARP zahteva, da se po modifikaciji kromatina PARP samospremeni in sprosti z DNA, da omogoči dostop encimom osnovnega popravljanja z izrezovanjem (BER - base excision repair).
White, opaque, size 0 hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink. 
Bela, neprozorna kapsula velikosti 0 z oznako "OLAPARIB 50 mg" in logom družbe AstraZeneca, natisnjenima s črnim črnilom.
In the placebo-treated group, 8.1% of patients remained on treatment for ≥2 years and 1.6% for ≥5 years. 
V skupini, ki je prejemala placebo, je bil ta delež za ≥ 2 leti 8,1 % in za ≥ 5 let 1,6 %.
Nonclinical studies in rats have shown that olaparib causes adverse effects on embryofoetal survival and induces major foetal malformations at exposures below those expected at the recommended human dose of 300 mg twice daily. 
Predklinične študije na podganah so pokazale, da ima olaparib neželene učinke na embrio-fetalno preživetje ter povzroča pomembne malformacije ploda pri izpostavljenostih, manjših od pričakovanih pri priporočenem odmerku za človeka 300 mg dvakrat na dan.
Tell your doctor straight away if you notice any of the following: 
Če opazite kaj od naslednjega, nemudoma obvestite zdravnika:
In a post-hoc analysis of the subgroup of patients that had not progressed on chemotherapy other than platinum, the median PFS in the olaparib arm (n=22) was 8.3 months (95% CI 3.1-16.7) and 2.8 months (95% CI 1.4-4.2) in the chemotherapy arm (n=16) with a HR of 0.54 (95% CI 0.24-1.23). 
V post-hoc analizi podskupin bolnikov, pri katerih bolezen ni napredovala med kemoterapijo brez platine, je bilo mediano PFS v skupini z olaparibom (n = 22) 8,3 meseca (95 % IZ: 3,1 do 16,7) in v skupini s kemoterapijo (n = 16) 2,8 meseca (95 % IZ: 1,4 do 4,2); ROg je bilo 0,54 (95 % IZ: 0,24 do 1,23).
There was no strategy for multiple testing in place for the sub-group analyses or for the all patients TFST. 
Za analize podskupin ter za vse bolnice s TFST ni bila uporabljena korekcija za večkratna testiranja.
Gender (%) Female Male 
Spol (%)
In patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min), AUC increased by 44% and Cmax by 26% compared with patients with normal renal function. 
Pri bolnicah z zmerno okvaro ledvic (očistek kreatinina 31 do 50 ml/min) je bila vrednost AUC povečana za 44 % in vrednost Cmax za 26 % v primerjavi z bolnicami z normalnim delovanjem ledvic.
When dosed orally to rats, olaparib induced micronuclei in bone marrow. 
Peroralno uporabljeni olaparib je pri podganah povzročil pojav mikrojeder v kostnem mozgu.
Due to the effect of food on olaparib absorption, patients should take Lynparza at least one hour after food, and refrain from eating preferably for up to 2 hours afterwards. 
Hrana vpliva na absorpcijo olapariba, zato morajo bolnice zdravilo Lynparza vzeti vsaj eno uro po jedi ter po možnosti ne smejo jesti do 2 uri po uporabi zdravila.
In vitro, data also show that olaparib is not a substrate for OATP1B1, OATP1B3, OCT1, BCRP or MRP2 and is not an inhibitor of OATP1B3, OAT1 or MRP2. 
Podatki in vitro tudi kažejo, da olaparib ni substrat OATP1B1, OATP1B3, OCT1, BCRP ali MRP2 in ni zaviralec OATP1B3, OAT1 ali MRP2.
In clinical studies with Lynparza the incidence of CTCAE grade ≥2 shifts (elevations) from baseline in blood creatinine was approximately 10%. 
V kliničnih študijah zdravila Lynparza je bila pojavnost sprememb (zvišanj) kreatinina v krvi ≥ 2. stopnje po CTCAE v primerjavi z izhodiščem približno 10 %.
Number of objective responders: Total number of patients with measurable disease (%) 
Število bolnikov z objektivnim odzivom: celotno število bolnikov z merljivo boleznijo (%) 95% IZ
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). 
C-olapariba pri bolnicah je šla večina radioaktivnosti v plazmi (70 %) na račun nespremenjenega olapariba, ki je bil tudi glavna snov v urinu in blatu (15 % odmerka v urinu in 6 % v blatu).
First-line maintenance treatment of BRCA-mutated advanced ovarian cancer: SOLO1 Study 
Prva linija vzdrževalnega zdravljenja napredovalnega raka jajčnikov in mutacijo gena BRCA: Študija SOLO1
In replicating cells this also leads to the formation of DNA double-strand breaks (DSBs) when replication forks meet the PARP-DNA adducts. 
V celicah, ki se razmnožujejo, to povzroči tudi nastanek dvoverižne prekinitve DNA (DSBs-double-strand breaks), ko podvojevalne vilice naletijo na adukt PARP-DNA.
It is not known whether Lynparza passes into semen. 
Ni znano, ali zdravilo Lynparza prehaja v seme (spermo).
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). 
Zdravilo Lynparza se lahko daje bolnikom z blago ali zmerno okvaro jeter (klasifikacija Child-Pugh A ali B) brez prilagoditve odmerka (glejte poglavje 5.2).
Demographic and baseline characteristics were generally well balanced between the olaparib and comparator arms (see Table 7). 
Demografske in izhodiščne značilnosti so bile med skupino z olaparibom in skupino s primerjalnim zdravilom na splošno dobro uravnotežene (glejte preglednico 7).
• you have certain side effects while you are taking Lynparza (see section 4). 
• če se vam med jemanjem zdravila Lynparza pojavijo določeni neželeni učinki (glejte poglavje 4).
If strong or moderate CYP3A inhibitors must be coadministered, the dose of Lynparza should be reduced. 
Če je treba sočasno uporabiti močne ali zmerne zaviralce CYP3A, je treba odmerek zdravila Lynparza zmanjšati.
Ovarian cancer was the primary tumour in 85% of the patients. 
Rak jajčnikov je bil primarni tumor pri 85 % bolnic.
• The usual recommended dose is 300 mg (2 x 150 mg tablets) twice a day - a total of 4 tablets each day. 
• Običajni priporočeni odmerek je 300 mg (dve 150 mg tableti) dvakrat na dan - skupaj 4 tablete vsak dan.
Patients who have received two or more platinum-containing regimens and whose disease had recurred >6 months after completion of penultimate platinum-based chemotherapy were enrolled. 
Vključene so bile bolnice, ki so prejemale dve ali več shem s platino in se jim je bolezen ponovila > 6 mesecev po dokončanju predzadnje predhodne kemoterapije na osnovi platine.
Throw away any Lynparza capsules that have been frozen. 
Kapsule zdravila Lynparza, ki so bile zamrznjene, morate zavreči.
95% CI 
ROg a 95 % IZ
bd Twice daily; DCO Data cut off; FAS Full analysis set; OS Overall survival 
DCO = datum zamejitve podatkov; FAS (full analysis set) = polni nabor za analizo
At 2 years, 43% olaparib-treated patients remained progression free compared with only 15% placebo-treated patients. 
Po 2 letih je bilo brez napredovanja bolezni 43 % bolnic, zdravljenih z olaparibom, in le 15 % bolnic, ki so prejemale placebo.
In clinical studies with the tablet formulation, the incidence of anaemia adverse reactions was 38.8% (CTCAE grade ≥3 17.4%) and the incidences of dose interruptions, reductions and discontinuations for anaemia were 15.7%, 10.8% and 1.9%, respectively; 20.9% of patients treated with olaparib needed one or more blood transfusions. 
V kliničnih študijah zdravila v obliki tablet je bila pojavnost neželenih učinkov anemije 38,8 % (≥ 3. stopnje po CTCAE 17,4 %), pojavnost prekinitev uporabe 15,7 %, zmanjšanj odmerka 10,8 % in prenehanj uporabe 1,9 %; 20,9 % bolnic, ki so prejemale olaparib, je med zdravljenjem potrebovalo eno ali več transfuzij.
Confirmed ORR - DCO 09 December 2016 
Potrjeni ORR - DCO 09. december 2016
The most frequent adverse reactions leading to dose interruption or dose reduction were nausea, anaemia, vomiting, neutropenia and fatigue. 
Najpogostejši neželeni učinki, ki so povzročili prekinitev uporabe ali zmanjšanje odmerka, so bili navzea, anemija, bruhanje, nevtropenija in utrujenost.
What Lynparza contains The active substance is olaparib. 
Kaj vsebuje zdravilo Lynparza Učinkovina je olaparib.
The key efficacy findings from Study 19 for BRCA-mutated patients are presented in Table 2, and Figures 1 and 2. 
Ključne izsledke o učinkovitosti iz študije 19 za bolnice z mutacijo gena BRCA prikazujejo preglednica 2 in sliki 1 in 2.
A statistically significant improvement in PFS, the primary efficacy outcome, was demonstrated for olaparib-treated patients compared with those in the comparator arm (see Table 8 and Figure 6). 
Pri bolnikih, zdravljenih z olaparibom, je bilo preživetje brez napredovanja bolezni (ki je bilo primarni opazovani dogodek učinkovitosti) statistično značilno boljše kot pri bolnikih v primerjalni skupini (glejte preglednico 8 in sliko 6).
If MDS and/or AML are confirmed while on treatment with Lynparza, it is recommended that Lynparza should be discontinued and the patient be treated appropriately. 
Če je med zdravljenjem z zdravilom Lynparza potrjen MSD in/ali AML, je priporočljivo uporabo zdravila Lynparza prekiniti in bolnike ustrezno zdraviti.
In clinical studies with Lynparza the incidence of CTCAE grade ≥2 shifts (decreases) from baseline in haemoglobin was 20%, absolute neutrophils 20%, platelets 5%, lymphocytes 30% and leucocytes 20% (all % approximate). 
V kliničnih študijah z zdravilom Lynparza je bila pojavnost sprememb (zmanjšanj) ≥ 2. stopnje po CTCAE od izhodišča za hemoglobin 20 %, absolutno število nevtrofilcev 20 %, trombocitov 5 %, limfocitov 30 % in levkocitov 20 % (vsi odstotki so približni).
The primary endpoint was PFS assessed by blinded independent central review (BICR) using RECIST 1.1. 
Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni, ocenjeno s slepljenim neodvisnim centralnim pregledom (BICR - blinded independent central review) in uporabo RECIST 1.1.
Tell your doctor, pharmacist or nurse if you are taking or are planning to take any of the following medicines: 
Zdravniku, farmacevtu ali medicinski sestri morate povedati, če jemljete ali boste morda začeli jemati katero od naslednjih zdravil:
After this period, throw away any capsules that have not been used. 
Vse kapsule, ki jih v tem obdobju ne porabite, morate zavreči.
Patients should not start treatment with Lynparza until they have recovered from haematological toxicity caused by previous anticancer therapy (haemoglobin, platelet and neutrophil levels should be ≤CTCAE grade 1). 
Bolniki ne smejo začeti zdravljenja z zdravilom Lynparza, dokler ne okrevajo po hematotoksičnih učinkih predhodnega zdravljenja proti raku (koncentracije hemoglobina, trombocitov in nevtrofilcov morajo biti stopnje 1 ali manj po CTCAE).
Retreatment with olaparib was not permitted following progression on olaparib. 
Če je bolezen med uporabo olapariba napredovala, ponovno zdravljenje z olaparibom ni bilo dovoljeno.
What Lynparza is and what it is used for 
Kaj je zdravilo Lynparza in za kaj ga uporabljamo
At the time of the analysis of PFS the median duration of treatment was 19.4 months for olaparib and 5.6 months for placebo. 
V času analize preživetja brez napredovanja bolezni je prejemanje olapariba mediano trajalo 19,4 meseca in placeba 5,6 meseca.
Secondary efficacy endpoints included OS (overall survival), DCR (disease control rate) defined as confirmed CR/PR + SD (stable disease), HRQoL (health related quality of life), and disease related symptoms. 
Sekundarni cilji študije so obsegali celokupno preživetje (OS), delež obvladanja bolezni (DCR - disease control rate), opredeljen kot potrjen CR/PR + SD (stabilna bolezen), zdravstveno kakovost življenja in z boleznijo povezane simptome.
• The usual recommended dose is 8 capsules (400 mg) taken by mouth twice a day (a total of 16 capsules each day). 
• Običajni priporočeni odmerek je 8 kapsul (400 mg) in ga je treba zaužiti dvakrat na dan (skupaj 16 kapsul vsak dan).
One pack contains 448 capsules (4 bottles of 112 capsules). 
Eno pakiranje vsebuje 448 kapsul (4 plastenke po 112 kapsul).
The limited data for these somatic tumour BRCA (sBRCA) mutated patients show that fewer patients on olaparib reported progression events or death events compared with placebo (Table 3). 
Maloštevilni podatki o bolnicah s temi somatskimi tumorskimi mutacijami gena BRCA (sBRCA) kažejo, da je bilo dogodkov napredovanja bolezni ali smrti med prejemnicami olapariba manj kot med prejemnicami placeba (preglednica 3).
Women of childbearing potential/contraception in females Women of childbearing potential should not become pregnant while on Lynparza and not be pregnant at the beginning of treatment. 
Ženske v rodni dobi ne smejo biti noseče na začetku zdravljenja z zdravilom Lynparza in ne smejo zanositi med zdravljenjem.
Male patients and their female partners of childbearing potential should use reliable contraception during therapy and for 3 months after receiving the last dose of Lynparza (see section 4.6). 
Moški bolniki in njihove partnerke v rodni dobi morajo med zdravljenjem in še 3 mesece po prejetju zadnjega odmerka zdravila Lynparza uporabljati zanesljivo kontracepcijo (glejte poglavje 4.6).
-----olaparib 400 mg bd twice daily, ____ placebo, x-axis=time from randomisation in months, yaxis=PFS (progression-free survival), n-olaparib= number of patients at risk-olaparib, n-placebo=number of patients at risk-placebo 
-----olaparib 400 mg dvakrat na dan, ____placebo, os x = čas od randomizacije v mesecih, os y = PFS (preživetje brez napredovanja bolezni), n-olaparib = število ogroženih bolnic-olaparib, n-placebo = število ogroženih bolnic-placebo
Lynparza co-administration with strong or moderate CYP3A inducers is not recommended. 
Sočasna uporaba zdravila Lynparza in močnih ali zmernih induktorjev CYP3A ni priporočljiva.
Haematological toxicity has been reported in patients treated with Lynparza, including clinical diagnoses and/or laboratory findings of generally mild or moderate (CTCAE grade 1 or 2) anaemia, neutropenia, thrombocytopenia and lymphopenia. 
Pri bolnikih, zdravljenih z zdravilom Lynparza, so bili opisani hematotoksični učinki, vključno s klinično diagnozo in/ali laboratorijskimi izsledki, na splošno blage ali zmerne (stopnja 1 ali 2 po CTCAE) anemije, nevtropenije, trombocitopenije in limfocitopenije.
In patients with mild renal impairment (creatinine clearance 51 to 80 ml/min), AUC increased by 24% and Cmax by 15% compared with patients with normal renal function. 
Pri bolnicah z blago okvaro ledvic (očistek kreatinina 51 do 80 ml/min) je bila vrednost AUC povečana za 24 % in vrednost Cmax za 15 % v primerjavi z bolnicami z normalnim delovanjem ledvic.
Please note Lynparza is also available as a 50 mg capsule. 
Vedeti morate, da je zdravilo Lynparza na voljo tudi v obliki 50 mg kapsul.
A clinical study to evaluate the impact of itraconazole, a known CYP3A inhibitor, has shown that coadministration with olaparib increased mean olaparib Cmax by 42% (90% CI: 33-52%) and mean AUC by 170% (90% CI: 144-197%). 
Klinična študija za oceno vpliva itrakonazola, ki je znan zaviralec CYP3A, je pokazala, da je njegova sočasna uporaba z olaparibom povečala srednjo vrednost Cmax olapariba za 42 % (90 % IZ: 33 do 52 %) in srednjo vrednost AUC olapariba za 170 % (90 % IZ:144 do 197 %).
In BRCA1/2-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 that correlated with the period of olaparib maintenance treatment. 
V modelih pomanjkanja gena BRCA1/2 in vivo je olaparib, uporabljen po zdravljenju na osnovi platine, upočasnil napredovanje tumorja in je podaljšal celokupno preživetje v primerjavi s samostojnim zdravljenjem na osnovi platine, ki je koreliral z obdobjem vzdrževalnega zdravljenja z olaparibom.
Figure 5 Study 19: Kaplan Meier plot of OS in the FAS (79% maturity) DCO 09 May 2016 
Slika 5 Študija 19: Kaplan-Meierjevi krivulji celokupnega preživetja v FAS (79 % zrelost) DCO 9. maj 2016
HDPE plastic bottle with a child-resistant closure containing 112 hard capsules. 
Plastenka iz HDPE z zaporko, varno za otroke; vsebuje 112 trdih kapsul.
PFS (63% maturity) 
PFS (~63 % zrelost)
Capsule shell Hypromellose Titanium dioxide (E171) Gellan gum (E418) Potassium acetate 
Ovojnica kapsule hipromeloza titanov dioksid (E171) gelanski gumi (E418) kalijev acetat
The time from randomisation to start of second subsequent therapy or death (TSST) was 6.1 months longer for olaparib-treated patients (HR 0.43; 95% CI 0.29-0.64; p=0.00003; median 21.4 months versus 15.3 months). 
Čas od randomizacije do začetka drugega nadaljnjega zdravljenja ali smrti (TSST) je bil med prejemnicami olapariba 6,1 meseca daljši (ROg 0,43; 95 % IZ: 0,29 do 0,64, p = 0,00003; mediana 21,4 meseca v primerjavi s 15,3 meseca).
For germline breast cancer susceptibility genes (gBRCA1/2) mutated human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, patients must have confirmation of a deleterious or suspected deleterious gBRCA1/2 mutation before Lynparza treatment is initiated. 
Bolniki, ki imajo HER2- (receptor humanega epidermalnega rastnega faktorja 2) negativnega metastatskega raka dojk z germinalno mutacijo genov dovzetnosti za raka dojk (gBRCA1/2), morajo imeti pred uvedbo zdravila Lynparza potrjeno škodljivo ali domnevno škodljivo mutacijo gBRCA1/2.
• Capsule shell: hypromellose, titanium dioxide (E171), gellan gum (E418), potassium acetate. 
• Ovojnica kapsule: hipromeloza, titanov dioksid (E171), gelanski gumi (E418), kalijev acetat.
Patients with germline or somatic BRCA1/2 mutations were identified prospectively either from germline testing in blood via a local test (n=208) or central test (n=181) or from testing a tumour sample using a local test (n=2). 
Bolnice z germinalnimi ali somatskimi mutacijami gena BRCA1/2 so identificirali prospektivno bodisi s testiranjem germinalne linije v krvi z lokalnim testom (n = 208) ali s centralnim testiranjem (n = 181) bodisi s testiranjem vzorca tumorja z lokalnim testom (n = 2).
In replicating cells this leads to DNA double strand breaks (DSBs) when replication forks meet the PARP-DNA adduct. 
V celicah, ki se razmnožujejo, to povzroči dvoverižne prekinitve DNA (DSBs-double-strand breaks), ko podvojevalne vilice naletijo na adukt PARP-DNA.
There is limited experience of overdose with olaparib. 
Izkušenj s prevelikim odmerjanjem olapariba je malo.
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide black (E172) (150 mg tablets only) 
Obloga tablete hipromeloza makrogol 400 titanov dioksid (E171) rumeni železov oksid (E172) črni železov oksid (E172) (samo 150-mg tablete)
There are limited clinical data available in non-Caucasian patients. 
Kliničnih podatkov o bolnikih, ki niso belci, je malo.
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. 
V modelih pomanjkanja gena BRCA in vivo je olaparib, uporabljen po zdravljenju na osnovi platine, upočasnil napredovanje tumorja in je podaljšal celokupno preživetje v primerjavi s samostojnim zdravljenjem na osnovi platine.
What Lynparza contains 
Kaj vsebuje zdravilo Lynparza
• if you experience any new or worsening symptoms of shortness of breath, coughing, or wheezing. 
• če se vam na novo pojavijo ali se vam poslabšajo kratka sapa, kašelj ali piskajoče dihanje.
The recommended dose reduction is to 250 mg (one 150 mg tablet and one 100 mg tablet) twice daily (equivalent to a total daily dose of 500 mg). 
Priporočeno zmanjšanje odmerka je na 250 mg (ena 150-mg tableta in ena 100-mg tableta) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 500 mg).
There are limited data in patients with somatic BRCA mutated tumours; 10 patients in the olaparib arm and 10 patients in the placebo arm were defined as having somatic BRCA1/2 mutation. 
Podatkov pri bolnicah s somatsko tumorsko mutacijo BRCA je malo; Somatsko mutacijo gena BRCA1/2 je imelo 10 bolnic v skupini z olaparibom in 10 bolnic v skupini s placebom.
At the time of the analysis of PFS the median duration of treatment was 8 months for olaparib and 4 months for placebo. 
V času analize preživetja brez napredovanja bolezni je prejemanje olapariba mediano trajalo 8 mesecev in placeba 4 meseca.
Figure 6 OlympiAD: Kaplan-Meier plot of BICR PFS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (77% maturity) DCO 09 December 2016 
Slika 6 OlympiAD: Kaplan-Meierjev prikaz PFS (BICR) pri bolnikih s HER2-negativnim metastatskim rakom dojk z mutacijo gBRCA1/2 (77 % zrelost), DCO 09. december 2016
Effect of other medicinal products on olaparib 
Farmakokinetično medsebojno delovanje Vpliv drugih zdravil na olaparib
-----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 
-----olaparib 400 mg dvakrat na dan, ____placebo, os x = čas od randomizacije, os y = OS (celokupno preživetje), n-olaparib = število ogroženih bolnic-olaparib, n-placebo = število ogroženih bolnic-placebo
Patients with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy should start treatment with Lynparza no later than 8 weeks after completion of their final dose of the platinum-containing regimen. 
Bolnice s ponovitvijo (PSR - platinum sensitive relapsed) epitelijskega raka visokega gradusa z izvorom v jajčnikih, jajcevodih ali peritoneju, občutljivega na platino, ki so v odzivu (popolnem ali delnem) na kemoterapijo na osnovi platine, morajo začeti zdravljenje z zdravilom Lynparza najpozneje v 8 tednih po zadnjem odmerku sheme zdravljenja na osnovi platine.
Do not drink grapefruit juice while you are being treated with Lynparza. 
Med jemanjem zdravila Lynparza ne pijte grenivkinega soka.
Olaparib inhibits CYP3A4 in vitro and is predicted to be a mild CYP3A inhibitor in vivo. 
Olaparib in vitro zavira CYP3A4 ter in vivo predvidoma blago zavira CYP3A.
In normal cells, homologous recombination repair (HRR), which requires functional BRCA1 and 2 genes, is effective at repairing these DNA DSBs. 
V normalnih celicah te dvoverižne prekinitve DNA učinkovito odpravi homologno popravljanje z rekombinacijo (HRR - homologous recombination repair), ki pa zahteva funkcionalna gena BRCA 1 in 2.
Haematological toxicity 
Hematološki toksični učinki
Figure 4 Study 19: Kaplan-Meier plot of PFS in the FAS (58% maturity - investigator assessment) DCO 30 June 2010 
Slika 4 Študija 19: Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni v FAS (58 % zrelost - raziskovalčeva ocena) DCO 30. junij 2010
Pack of 448 capsules (4 bottles of 112 capsules). 
Pakiranje s 448 kapsulami (4 plastenke po 112 kapsul).
bd Twice daily; PFS progression-free survival; DCO data cut off; CI confidence interval; NR not reached. 
PFS = preživetje brez napredovanja bolezni, DCO = datum zamejitve podatkov, IZ = interval zaupanja, ND = ni doseženo
The investigator assessment of PFS was supported with a blinded independent central radiological review of PFS (HR 0.25; 95% CI 0.18-0.35; p<0.0001; median 30.2 months for olaparib and 5.5 months placebo). 
Raziskovalčevo oceno PFS je potrdil slepljen neodvisen centralni radiološki pregled glede PFS (ROg 0,25, 95 % IZ 0,18 do 0,35, p < 0,0001, mediana 30,2 meseca z olaparibom in 5,5 meseca s placebom).