natgillin/translations-raw huggingface dataset:
Baseline testing, followed by monthly monitoring of complete blood counts is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment which may require dose interruption or reduction and/or further treatment (see sections 4.2 and 4.4). 
Preiskava celotne krvne slike je priporočljiva na začetku zdravljenja, potem vsak mesec prvih 12 mesecev zdravljenja in pozneje redno, da bi med zdravljenjem odkrili klinično pomembne spremembe katere koli vrednosti, ki bi zahtevala prekinitev ali zmanjšanje odmerka in/ali dodatno zdravljenje (glejte poglavji 4.2 in 4.4).
C-olaparib, ~86% of the dosed radioactivity was recovered within a 7-day collection period, ~44% via the urine and ~42% via the faeces. 
C-olapariba se je v 7 dneh zbiranja izločilo ~86 % radioaktivnega odmerka, ~44 % v urinu in ~42 % v blatu.
56 film-coated tablets (7 blisters). 
56 filmsko obloženih tablet (7 pretisnih omotov).
Anaemia and other haematological toxicities were generally low grade (CTCAE grade 1 or 2), however, there were reports of CTCAE grade 3 and higher events. 
Anemija in drugi hematotoksični učinki so bili na splošno nizke stopnje (1 ali 2 po CTCAE), vendar so bili opisani tudi dogodki stopnje 3 ali več po CTCAE.
Studies in animals have shown reproductive toxicity including serious teratogenic effects and effects on embryofoetal survival in the rat at maternal systemic exposures lower than those in humans at therapeutic doses (see section 5.3). 
Študije na živalih so pri podganah pokazale vpliv na sposobnost razmnoževanja, vključno z resnimi teratogenimi učinki in vplivom na embrio-fetalno preživetje pri sistemskih izpostavljenostih samicmater, manjših od izpostavljenosti pri človeku v terapevtskih odmerkih (glejte poglavje 5.3).
In population based PK analyses, patient age, gender, bodyweight or race (including White and Japanese patients) were not significant covariates. 
V populacijski farmakokinetični analizi starost bolnikov, spol, telesna masa ali rasa (vključno z bolniki belci in japonskimi bolniki) niso bile pomembne sospremenljivke.
In vitro, human plasma protein binding of olaparib was dose-dependent; the fraction bound was approximately 91% at 1 µg/mL, reducing to 82% at 10 µg/mL and to 70% at 40 µg/mL. 
In vitro je bila vezava olapariba na beljakovine v humani plazmi odvisna od odmerka; vezani delež je bil pri koncentraciji 1 µg/ml približno 91 % in se je pri koncentraciji 10 µg/ml zmanjšal na 82 % in pri koncentraciji 40 µg/ml na 70 %.
• Your doctor will tell you how many tablets of Lynparza to take. 
• Zdravnik vam bo povedal, koliko tablet zdravila Lynparza morate vzeti.
Large rearrangements in the BRCA1/2 genes were detected in 7.4% (10/136) of the randomised patients. 
Velike preureditve genov BRCA1/2 so ugotovili pri 7,4 % (10/136) randomiziranih bolnic.
Olaparib is a type of cancer medicine called a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor). 
Olaparib je vrsta zdravila proti raku, ki jih imenujemo zaviralci PARP (zaviralec poli [adenozin-difosfat-riboza] polimeraze).
• Swallow Lynparza tablets whole, with or without food. 
• Tablete zdravila Lynparza morate pogoltniti cele, s hrano ali brez nje.
• telithromycin, clarithromycin, erythromycin - used for bacterial infections 
• telitromicin, klaritromicin, eritromicin - uporabljajo se za zdravljenje bakterijskih okužb,
Number of events: Total number of patients (%) 
Število dogodkov: celotno število bolnikov (%)
Female patients: 
Ženske bolnice:
Ovarian cancer was the primary tumour in >80% of the patients. 
Rak jajčnikov je bil primarni tumor pri > 80 % bolnic.
Co-administration with food slowed the rate (tmax delayed by 2.5 hours and Cmax reduced by approximately 21%) but did not significantly affect the extent of absorption of olaparib (AUC increased 8%). 
Sočasna uporaba s hrano je upočasnila hitrost absorpcije (podaljšanje tmax za 2,5 ure in zmanjšanje vrednosti Cmax za približno 21 %), ni pa bistveno vplivala na obseg absorpcije olapariba (povečanje vrednosti AUC za 8 %).
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. 
Analiza celokupnega preživetja pri bolnikih brez predhodne kemoterapije za metastatskega raka dojk je pri teh bolnikih pokazala korist z ROg 0,45 (95 % IZ: 0,27 do 0,77), medtem ko je pri nadaljnjih linijah zdravljenja ROg presegalo 1.
All patients had received first-line platinum-based therapy. 
Vse bolnice so prejele zdravljenje prve linije na osnovi platine.
Following oral administration of olaparib via the capsule formulation, absorption is rapid with peak plasma concentrations typically achieved between 1 to 3 hours after dosing. 
Po peroralni uporabi olapariba v kapsulah je absorpcija hitra in največja koncentracija v plazmi je praviloma dosežena od 1 do 3 ure po uporabi.
Nausea events led to dose interruption and dose reductions in 14% and 4%, respectively, of olaparib-treated patients. 
Primeri navzee so vodili do prekinitve uporabe pri 14 % in zmanjšanja odmerka pri 4 % bolnic, zdravljenih z olaparibom.
It is not known whether olaparib or its metabolites are found in seminal fluid. 
Ni znano, ali se olaparib ali njegovi presnovki pojavijo v semenski tekočini.
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%). 
Neželeni učinki ≥ 3. stopnje, ki so se pojavili pri > 2 % bolnic so bili anemija (16 %), nevtropenija (6 %), utrujenost/astenija (6 %), levkopenija (3 %), trombocitopenija (2 %) in bruhanje (2 %).
Lynparza is used for the treatment of a type of ovarian cancer called “BRCA-mutated ovarian cancer”. 
Zdravilo Lynparza uporabljamo za zdravljenje raka jajčnikov, imenovanega "rak jajčnikov z mutiranim genom BRCA".
• Capsule content: lauroyl macrogol-32 glycerides. 
• Vsebina kapsule: makrogolglicerol lavrat-32.
After a number of rounds of replication, genomic instability can reach insupportable levels and result in cancer cell death, as cancer cells already have a high DNA damage load relative to normal cells. 
Po številnih ponovitvah replikacije lahko genomska nestabilnost doseže nevzdržno raven in povzroči odmrtje rakave celice, ker rakave celice že imajo veliko okvar DNA v primerjavi z normalnimi.
• Taking the wrong dose or a tablet instead of a capsule could lead to Lynparza not working properly or to more side effects. 
• Če vzamete napačen odmerek ali če vzamete tableto namesto kapsule, to lahko povzroči, da zdravilo Lynparza ne bo delovalo pravilno ali da bo imelo več neželenih učinkov.
Genetic counselling for patients with BRCA1/2 mutations should be performed according to local regulations. 
Genetsko svetovanje bolnicam z mutacijami gena BRCA1/2 je treba opraviti v skladu z lokalnimi predpisi.
This medicinal product contains 0.24 mg sodium per 100 mg tablet and 0.35 mg sodium per 150 mg tablet, i.e. essentially “sodium-free”. 
To zdravilo vsebuje 0,24 mg natrija na 100 mg tableto in 0,35 mg natrija na 150 mg tableto, kar v bistvu pomeni ‘brez natrija'.
Uncommon Hypersensitivity a, Dermatitis 
Bolezni imunskega sistema pogosti izpuščaj občasni preobčutljivost a, dermatitis
Induction of CYP1A2, 2B6 and 3A4 has been shown in vitro with CYP2B6 being most likely to be induced to a clinically relevant extent. 
In vitro so ugotovili indukcijo CYP1A2, 2B6 in 3A4; klinično pomembna indukcija je najverjetnejša pri CYP2B6.
Table 3 Summary of progression-free survival and overall survival: sBRCA mutated population in Study 19 
Povzetek preživetja brez napredovanja bolezni in celokupnega preživetja: populacija z mutacijo gena sBRCA v študiji 19
The median follow-up time in censored patients was 25.3 months for olaparib versus 26.3 months for comparator. 
Mediani čas spremljanja pri krnjenih bolnikih je bil 25,3 meseca v skupini z olaparibom in 26,3 meseca v skupini s primerjalnim zdravilom.
Using the same assay, the fraction bound to alpha-1 acid glycoprotein was 29% at 10 µg/mL with a trend of decreased binding at higher concentrations. 
Z uporabo istega preskusa je bil na alfa-1 kisli glikoprotein vezani delež ob koncentraciji 10 µg/ml 29 % in opazen je bil trend zmanjševanja vezave pri večjih koncentracijah.
TFST (49% maturity) 
TFST (49 % zrelost)
• itraconazole, fluconazole - used for fungal infections 
• itrakonazol, flukonazol - uporabljata se za zdravljenje glivičnih okužb,
In vitro, olaparib is a substrate of the efflux transporter P-gp, however, this is unlikely to be of clinical significance (see section 4.5). 
In vitro je olaparib substrat iztočnega prenašalca P-gp, vendar ni verjetno, da bi bilo to klinično pomembno (glejte poglavje 4.5).
• Taking the wrong dose or a capsule instead of a tablet could lead to Lynparza not working properly or to more side effects. 
• Če vzamete napačen odmerek ali če vzamete kapsulo namesto tablete, to lahko povzroči, da zdravilo Lynparza ne bo delovalo pravilno ali da bo imelo več neželenih učinkov.
In the event of an overdose, physicians should follow general supportive measures and should treat the patient symptomatically. 
V primeru prevelikega odmerjanja je treba uporabiti splošne podporne ukrepe in bolnike simptomatsko zdraviti.
There are no efficacy or safety data on maintenance retreatment with Lynparza following first or subsequent relapse in ovarian cancer patients or on retreatment of breast cancer patients (see section 5.1). 
Podatkov o učinkovitosti ali varnosti za ponovno vzdrževalno zdravljenje z zdravilom Lynparza po prvi ali poznejši ponovitvi bolezni pri bolnicah z rakom jajčnikov ali za ponovno zdravljenje bolnikov z rakom dojk ni (glejte poglavje 5.1).
There is no requirement for BRCA1/2 testing prior to using Lynparza for the maintenance treatment of relapsed EOC, FTC or PPC who are in a complete or partial response to platinum-based therapy. 
Testiranje BRCA1/2 ni potrebno pred uporabo zdravila Lynparza za vzdrževalno zdravljenje ponovitve EOC, FTC ali PPC, če ima bolnica popoln ali delen odziv na zdravljenje na osnovi platine.
There are no data on retreatment with Lynparza following subsequent relapse (see section 5.1). 
Podatkov o ponovnem zdravljenju z zdravilom Lynparza po poznejši ponovitvi bolezni ni (glejte poglavje 5.1).
Patients were randomised into the study a median of 40 days after completing their final platinum chemotherapy. 
Bolnice so bile v študijo randomizirane mediano 40 dni po dokončanju zadnje kemoterapije na osnovi platine.
Do not switch to Lynparza capsules unless your doctor tells you 
Ne preidite na jemanje kapsul zdravila Lynparza, razen če vam tako naroči zdravnik.
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). 
In vitro olaparib zavira efluksni prenašalec P-gp (IC50 = 76 µM), zato ni mogoče izključiti klinično pomembnih medsebojnih delovanj olapariba s substrati P-gp (npr. s simvastatinom, pravastatinom, dabigatranom, digoksinom in kolhicinom).
• The doses of Lynparza capsules and tablets are not the same. 
• Odmerki zdravila v kapsulah in tabletah zdravila Lynparza niso enaki.
• statins, for example simvastatin, pravastatin, rosuvastatin - used to lower blood cholesterol levels 
• statini, na primer simvastatin, pravastatin, rosuvastatin - uporabljajo se za zmanjševanje koncentracije holesterola v krvi,
PFS (51% maturity) 
PFS (51 % zrelost)
Paediatric population No studies have been conducted to investigate the pharmacokinetics of olaparib in paediatric patients. 
Pediatrična populacija Študij farmakokinetike olapariba pri pediatričnih bolnikih niso izvedli.
There are limited clinical data in patients aged 75 years and over. 
Kliničnih podatkov o bolnikih, starih 75 let ali več, je malo.
Olaparib 300 mg bd n=205 
olaparib 300 mg 2x na dan n = 205
Response to prior platinum chemotherapy was complete in 45% and partial in 55% of the patients. 
Odziv na predhodno kemoterapijo na osnovi platine je bil popoln pri 45 % bolnic in delen pri 55 % bolnic.
Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2mutations, who have HER2 negative locally advanced or metastatic breast cancer. 
Zdravilo Lynparza je indicirano kot monoterapija za zdravljenje odraslih bolnikov z germinalno mutacijo gena BRCA1/2, ki imajo HER2-negativnega lokalno napredovalega ali metastatskega raka dojk.
You should have received chemotherapy medicines either before or after your cancer has spread. 
Pred ali po razširitvi raka ste morali prejemati zdravila za kemoterapijo.
Large rearrangements in the BRCA1/2 genes were detected in 5.5% (21/383) of the randomised patients. 
Velike preureditve genov BRCA1/2 so ugotovili pri 5,5 % (21/383) randomiziranih bolnic.
• The doses of Lynparza tablets and capsules are not the same. 
• Odmerki zdravila v tabletah in kapsulah zdravila Lynparza niso enaki.
Lynparza can be administered in patients with mild renal impairment (creatinine clearance 51 to 80 ml/min) with no dose adjustment. 
Zdravilo Lynparza se lahko pri bolnikih z blago okvaro ledvic (očistek kreatinina 51 do 80 ml/min) uporablja brez prilagoditve odmerka.
Approximately a quarter of placebo-treated patients in the BRCA-mutated subgroup (14/62; 22.6%) received a subsequent PARP inhibitor. 
Približno četrtina tistih bolnic v podskupini z mutacijo gena BRCA, ki so prejemale placebo (14/62, 22,6 %) je nato dobilo zaviralec PARP.
Maintenance treatment of platinum-sensitive relapsed (PSR) ovarian cancer SOLO2 Study 
Vzdrževalno zdravljenje na platino občutljive ponovitve (PSR) raka jajčnikov Študija SOLO2
The metabolism of olaparib is extensive. 
Presnova olapariba je obsežna.
Do not switch to Lynparza tablets unless your doctor tells you 
Ne preidite na jemanje tablet zdravila Lynparza, razen če vam tako naroči zdravnik.
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. 
Monoterapija z zdravilom Lynparza je bila povezana z neželenimi učinki, ki so bili na splošno blage ali zmerne resnosti (stopnja po CTCAE 1 ali 2) in na splošno niso zahtevali prekinitve zdravljenja.
In the TNBC patient subgroup the confirmed ORR was 48% (41/86) in the olaparib arm and 12% (4/33) in the comparator arm. 
V podskupini bolnikov s TNBC je bil potrjeni ORR 48 % (41/86) v skupini z olaparibom in 12 % (4/33) v skupini s primerjalnim zdravilom.
What Lynparza looks like and contents of the pack 
Izgled zdravila Lynparza in vsebina pakiranja
There are very limited data in patients with a somatic BRCA mutation. 
Podatkov pri bolnicah s somatskimi mutacijami gena BRCA je zelo malo.
Other special populations Limited safety data are available in elderly (age  75 years) and non-Caucasian patients. 
Druge posebne skupine bolnikov Varnostnih podatkov pri starejših bolnikih (starih  75 let) in bolnikih, ki niso belci, je malo.
Patients must have received treatment with an anthracycline unless contraindicated and a taxane in either a (neo)adjuvant or metastatic setting. 
Bolniki so morali prejemati zdravljenje z antraciklinom, razen če je bil kontraindiciran, in taksanom, bodisi v okviru (neo)adjuvantnega zdravljenja ali zdravljenja metastatske bolezni.
There was no strategy for multiple testing in place for the sub-group analyses. 
Za analize podskupin ni bila uporabljena korekcija za večkratna testiranja.
• rash or itchy rash on swollen, reddened skin (dermatitis) 
• izpuščaj ali srbeč izpuščaj na otekli, pordeli koži (dermatitis)
Detection of BRCA1/2 mutations 
Odkrivanje mutacij genov BRCA1/2
• dabigatran - used to thin the blood 
• dabigatran - uporablja se za redčenje krvi,
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. 
Farmakokinetika med uporabo olapariba v tabletah 300 mg kaže navidezni plazemski očistek ~7 L/uro, navidezni volumen porazdelitve ~158 L in končni razpolovni čas 15 ur.
BRCA1/2 wt/VUS 
Z mutacijo gena BRCA1/2 BRCA1/2 wt/VUS
Maintenance treatment of platinum sensitive relapsed ovarian cancer: 
Vzdrževalno zdravljenje na platino občutljive ponovitve raka jajčnikov:
Secondary endpoints included PFS2, OS, objective response rate (ORR) and HRQoL. 
Sekundarni opazovani dogodki so obsegali PFS2, OS, delež objektivnega odziva (ORR) in zdravstveno kakovost življenja (HRQoL).
You will be asked to take 6 capsules (300 mg) twice a day - a total of 12 capsules each day. 
Jemati boste morali 6 kapsul (300 mg) dvakrat na dan - skupaj 12 kapsul vsak dan,
No placebo-treated patients discontinued due to vomiting or dyspepsia. 
Nobena prejemnica placeba ni prekinila zdravljenja zaradi bruhanja ali dispepsije.
Median age was 59 years in both arms. 
Mediana starost je bila v obeh skupinah 59 let.
• changes in taste of foods (dysgeusia) 
• spremenjeno okušanje hrane (dizgevzija)
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). 
Vse bolnice obsega naslednje podskupine: mutacijo gena BRCA1/2, BRCA1/2 wt/VUS in neznano stanje BRCA1/2 (11 bolnic z neznanim statusom, v preglednici niso prikazane kot ločena podskupina).
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. 
Po številnih ponovitvah replikacije lahko genomska nestabilnost doseže nevzdržno raven in povzroči odmrtje rakave celice, ker imajo rakave celice v primerjavi z normalnimi veliko okvar DNA.
• glibenclamide, metformin, repaglinide - used to treat diabetes 
• glibenklamid, metformin, repaglinid - uporabljajo se za zdravljenje sladkorne bolezni,
Nausea was generally reported very early, with first onset within the first month of Lynparza treatment in the majority of patients. 
O navzei so na splošno poročali zelo zgodaj in se je pri večini bolnic prvič pojavila v prvem mesecu zdravljenja z zdravilom Lynparza.
Patients who take Lynparza may experience fatigue, asthenia or dizziness. 
Bolnikom, ki jemljejo zdravilo Lynparza, se lahko pojavijo utrujenost, astenija ali omotica.
Median age was 56 years in both arms. 
Mediana starost je bila v obeh skupinah 56 let.
It is also not recommended to consume grapefruit juice while on Lynparza therapy as it is a CYP3A inhibitor. 
Prav tako med zdravljenjem z zdravilom Lynparza ni priporočljivo pitje grenivkinega soka, ker ta zavira CYP3A.
The majority of reports were in germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2) mutation carriers. 
Večina opisanih primerov je bilo pri nosilkah germinalne mutacije gena dovzetnosti za raka dojk 1 ali 2 (gBRCA1/2).
Based on Kaplan-Meier estimates, the proportion of patients that were progression free at 24 and 36 months were 74% and 60% for olaparib versus 35% and 27% for placebo; the median follow-up time was 41 months for both the olaparib and placebo arms. 
Na podlagi Kaplan-Meierjevih ocen je bil delež bolnic brez napredovanja bolezni v skupini z olaparibom po 24 mesecih 74 % in po 36 mesecih 60 %, v skupini s placebom pa sta bila ta deleža 35 % in 27 %; mediani čas spremljanja je bil 41 mesecev tako v skupini z olaparibom kot v skupini s placebom.
All patients had evidence of gBRCA1/2m at baseline. 
Vse bolnice so imele izhodiščno potrjeno gBRCA1/2m.
In rat embryofoetal development studies, and at dose levels that did not induce significant maternal toxicity, olaparib caused reduced embryofoetal survival, reduced foetal weight and foetal developmental abnormalities, including major eye malformations (e.g. anophthalmia, microphthalmia), vertebral/rib malformation and visceral and skeletal abnormalities. 
V študijah embrio-fetalnega razvoja pri podganah je olaparib v odmerkih, ki niso imeli pomembnih toksičnih učinkov pri samicah-materah, zmanjšal embrio-fetalno preživetje in telesno maso plodov ter je povzročil razvojne nepravilnosti plodov vključno s hudimi malformacijami oči (npr. anoftalmijo, mikroftalmijo), malformacije vretenc oziroma reber ter visceralne in skeletne nepravilnosti.
Co-administration with food slowed the rate (tmax delayed by 2 hours) and marginally increased the extent of absorption of olaparib (AUC increased by approximately 20%). 
Sočasna uporaba s hrano je upočasnila hitrost absorpcije (podaljšanje tmax za 2 uri) in mejno povečala obseg absorpcije olapariba (povečanje vrednosti AUC za približno 20 %).
It can be used after the cancer has responded to previous treatment with standard platinum-based chemotherapy. 
Uporabi se lahko potem, ko se je rak odzval na predhodno zdravljenje s standardno kemoterapijo na osnovi platine.
The efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib (see also sections 4.4 and 4.6). 
Učinkovitost nekaterih hormonskih kontraceptivov se lahko zmanjša, če so uporabljeni sočasno z olaparibom (glejte tudi poglavji 4.4 in 4.6).
The recommended Lynparza monotherapy dose is not suitable for combination with myelosuppressive anticancer medicinal products. 
Zdravilo Lynparza se uporablja kot monoterapija in ni primerno za uporabo v kombinaciji z mielosupresivnimi zdravili proti raku.
Up to 20, 37 and 20 metabolites were detected in plasma, urine and faeces, respectively, the majority of them representing < 1% of the dosed material. 
V plazmi so odkrili do 20 presnovkov, v urinu do 37 in v blatu do 20; večina od teh je predstavljala < 1 % uporabljenega zdravila.
As subsequent therapy, 0.5% and 8% of patients received a PARP inhibitor in the treatment and comparator arms, respectively; 29% and 42% of patients, respectively, received subsequent platinum therapy. 
Kot nadaljnje zdravljenje je 0,5 % bolnikov v terapevtski in 8 % bolnikov v primerjalni skupini prejelo zaviralec PARP, 29 % bolnikov v prvi in 42 % v drugi skupini pa je v nadaljevanju prejelo zdravljenje s platino.
Pre-planned subgroup analysis by BRCA-mutation status identified patients with BRCA-mutated ovarian cancer (n=136, 51.3%) as the subgroup that derived the greatest clinical benefit from olaparib maintenance monotherapy. 
Poleg tega je vnaprej načrtovana analiza podskupin po mutacijskem stanju gena BRCA pokazala, da so bolnice z rakom jajčnikov in mutacijo gena BRCA (n = 136, 51,3 %) tista podskupina, ki ji je vzdrževalna monoterapija z olaparibom klinično najbolj koristila.
Baseline testing, followed by monthly monitoring, of complete blood counts is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment (see section 4.8). 
Preiskava celotne krvne slike je priporočljiva na začetku zdravljenja, potem vsak mesec prvih 12 mesecev zdravljenja in pozneje redno, da bi odkrili klinično pomembne spremembe katere koli vrednosti med zdravljenjem (glejte poglavje 4.8).
• You should have a pregnancy test before starting Lynparza, at regular times during treatment and 1 month after taking the last dose of Lynparza. 
• Pred začetkom jemanja zdravila Lynparza morate opraviti test nosečnosti, ki ga morate ponavljati v rednih presledkih ves čas zdravljenja in še en mesec po vzetju zadnjega odmerka zdravila Lynparza.
Tell your doctor, pharmacist or nurse if you are taking any of the above or any other medicines. 
Zdravniku, farmacevtu ali medicinski sestri povejte, če jemljete katero od navedenih zdravil ali katero koli drugo zdravilo.
PFS2 (65% maturity) - DCO 25 September 2017 
PFS2 (65 % zrelost) - DCO 25. september 2017
• a type of ovarian cancer (BRCA-mutated) that has responded to the first treatment with standard platinum-based chemotherapy. 
• raka jajčnikov posebne vrste (z mutacijo gena BRCA), ki se je odzval na prvo zdravljenje s standardno kemoterapijo na osnovi platine.
Each hard capsule contains 50 mg of olaparib. 
Ena trda kapsula vsebuje 50 mg olapariba.