natgillin/translations-raw huggingface dataset:
Randomisation within each cohort was stratified by time to progression after the penultimate platinum therapy before study enrollment (6 to < 12 months and ≥ 12 months); use or not of bevacizumab in conjunction with the penultimate or last platinum regimen; and best response during the most recent platinum regimen (complete response and partial response). 
Randomizacija znotraj vsake kohorte je bila stratificirana po času do napredovanja po predzadnji terapiji s platino pred vključitvijo v študijo (6 do < 12 mesecev in ≥ 12 mesecev), uporabi ali neuporabi bevacizumaba v povezavi s predzadnjim ali zadnjim režimom s platino ter najboljšem odzivu med zadnjim režimom s platino (popoln odziv in delni odziv).
Grade 3/4 hypertension occurred in 8.2 % of patients. 
Hipertenzija 3. ali 4. stopnje se je pojavila pri 8,2 % bolnic.
p-value Hazard ratio (HR) 
vrednost p razmerje tveganja (HR - hazard ratio)
Pancytopenia has been observed in < 1 % of patients receiving niraparib. 
Pancitopenijo so opazili pri < 1 % bolnic, ki so prejemale niraparib.
It is unknown whether niraparib or its metabolites are excreted in human milk. 
Ni znano, ali se niraparib ali njegovi presnovki izločajo v materino mleko.
Recommendations for the management of adverse reactions are provided in Table 1. 
Priporočila za obvladovanje neželenih učinkov so podana v preglednici 1.
Therefore, a clinically meaningful interaction related to an inhibition of these efflux transporters although unlikely, cannot be excluded. 
Zato klinično pomembnega medsebojnega delovanja v povezavi z zaviranjem teh izlivnih prenašalcev ni mogoče izključiti, čeprav je malo verjetno.
gBRCAmut non-gBRCAmut 
gBRCAmut ne-gBRCAmut
Brilliant blue FCF (E 133) Erythrosine (E 127) Tartrazine (E 102) 
želatina briljantno modro FCF (E 133) eritrozin (E 127) tartrazin (E 102)
The combination of niraparib with vaccines or immunosuppressant agents has not been studied. 
Kombinacije nirapariba s cepivi ali imunosupresivi niso proučili.
Effect of niraparib on other medicinal products 
Učinek nirapariba na druga zdravila
The cases were typical of secondary, cancer therapy-related MDS/AML. 
Primeri so bili značilni za sekundarna, z zdravljenjem proti raku povezana MDS/AML.
PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP). 
Zaviralci PARP blokirajo encim, ki mu pravimo poli-[adenozin-difosfat-riboza] polimeraza (PARP).
Radioactive recovery in the urine accounted for 47.5 % (range 33.4 % to 60.2 %) and in the feces for 38.8 % (range 28.3 % to 47.0 %) of the dose. 
Iz urina pridobljeni radioaktivni material je predstavljal 47,5 % (razpon od 33,4 % do 60,2 %) odmerka, iz blata pridobljeni pa 38,8 % (razpon od
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Bolnice z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
The primary efficacy analysis for PFS was determined by blinded central independent assessment and was prospectively defined and assessed for the gBRCAmut cohort and the non-gBRCAmut cohort separately. 
Analiza primarne učinkovitosti za PFS je bila ugotovljena s slepim centralnim neodvisnim ocenjevanjem ter prospektivno opredeljena in ločeno ocenjena za kohorto gBRCAmut in kohorto ne-gBRCAmut.
Patients were assigned to the gBRCAmut cohort based on blood samples for gBRCA analysis that were taken prior to randomisation. 
Bolnice so bile razporejene v kohorto gBRCAmut na osnovi vzorcev krvi za analizo, odvzetih pred randomizacijo.
The data on niraparib in combination with cytotoxic medicinal products are limited. 
Podatki o niraparibu v kombinaciji s citotoksičnimi zdravili so omejeni.
Zejula can cause high blood pressure, which in some cases, could be severe. 
Visok krvni tlak Zdravilo Zejula lahko povzroči visok krvni tlak, zvišanje je lahko v nekaterih primerih hudo.
In the clinical programme, hypertension was readily managed with anti-hypertensive medicinal products. 
V kliničnem programu so hipertenzijo brez težav obvladovali z zdravili proti hipertenziji.
Take your next dose at its scheduled time. 
Vzemite naslednji odmerek po običajnem razporedu.
Zejula should not be taken if you are breast-feeding as it is not known if it passes into breast milk. 
Zdravila Zejula ne smete jemati med dojenjem, saj ni znano, ali se izloča v materino mleko.
• Being short of breath, feeling very tired, having pale skin, or fast heartbeat -- these may be signs of a low red blood cell count (anaemia). 
• Pomanjkanje sape, občutek hude utrujenosti, bleda koža ali hiter srčni utrip - to je lahko znak nizkega števila rdečih krvničk (anemija).
Prior to unblinding of the study, tumours of patients were tested for the presence of HRD using an experimental HRD test, which evaluates three indirect measures of tumour genome instability: loss of heterozygosity, telomeric allelic imbalance (TAI), and large-scale state transitions. 
Pred razkritjem študije so bili tumorji bolnic testirani na prisotnost HRD z eksperimentalnim testom HRD, ki ovrednoti tri posredna merila nestabilnosti genoma tumorja: izgubo heterozigotnosti, neravnovesje telomer med aleli (TAI, telomeric allelic imbalance) in tranzicije velikega obsega.
Secondary efficacy endpoints included chemotherapy-free interval (CFI), time to first subsequent therapy (TFST), PFS after the first subsequent therapy (PFS2), time to second subsequent therapy (TSST) and OS (overall survival). 
chemotherapy-free interval), čas do prve naslednje terapije (TFST - time to first subsequent therapy), PFS po prvi naslednji terapiji (PFS2), čas do druge naslednje terapije (TSST - time to second subsequent therapy) in skupno preživetje (OS - overall survival).
In the pivotal ENGOT-OV16 study, adverse reactions (ADRs) occurring ≥ 10 % of patients receiving Zejula monotherapy were nausea, thrombocytopenia, fatigue/asthenia, anaemia, constipation, vomiting, abdominal pain, neutropenia, insomnia, headache, decreased appetite, nasopharyngitis, diarrhoea, dyspnea, hypertension, dyspepsia, back pain, dizziness, cough, urinary tract infection, arthralgia, palpitations, and dysgeusia. 
V osrednji študiji ENGOT-OV16 so bili neželeni učinki zdravila, ki so se pojavili pri ≥ 10 % bolnic, ki so prejemale monoterapijo z zdravilom Zejula, naslednji: navzea, trombocitopenija, utrujenost/astenija, anemija, zaprtje, bruhanje, bolečina v trebuhu, nevtropenija, nespečnost, glavobol, zmanjšan apetit, nazofaringitis, driska, dispneja, hipertenzija, dispepsija, bolečina v hrbtu, omotičnost, kašelj, okužba sečil, artralgija, palpitacije in disgevzija.
Niraparib is a type of anti-cancer medicine called a PARP inhibitor. 
Niraparib je vrsta zdravila proti raku, ki mu pravimo zaviralec PARP.
A high proportion of patients in both treatment arms in both cohorts had received 3 or more prior lines of chemotherapy, including 49 % and 34 % of niraparib patients in the gBRCAmut and non-gBRCAmut cohorts, respectively. 
Velik delež bolnic v obeh krakih zdravljenja v obeh kohortah je predhodno prejel 3 ali več linij kemoterapije, vključno z 49 % in 34 % odstotki bolnic, zdravljenih z niraparibom v kohortah gBRCAmut oziroma ne-gBRCAmut.
Pancytopenia, febrile neutropenia 
Občasni pancitopenija, febrilna nevtropenija
A reversible reduction of spermatogenesis was observed in rats and dogs (see section 5.3). 
Pri podganah in psih so opazili reverzibilno zmanjšanje spermatogeneze (glejte poglavje 5.3).
Each hard capsule shell also contains the colouring agent tartrazine (E 102) [0.0172 mg]. 
Poleg tega ovojnica trde kapsule vsebuje barvilo tartrazin (E 102) [0,0172 mg].
In a mass balance study, M1 and M10 (the subsequently formed M1 glucuronides) were the major circulating metabolites. 
V študiji masnega ravnovesja sta bila glavna presnovka v obtoku M1 in M10 (pozneje nastali glukuronidi M1).
Uncommon (may affect up to 1 in 100 people) • Reduction in the number of red blood cells, white blood cells and platelets 
Občasni (pojavijo se lahko pri največ 1 od 100 bolnic): • znižanje števila rdečih krvničk, belih krvničk in krvnih ploščic.
• Inflammation or swelling of the air passages between the mouth and nose and the lungs, 
• vnetje ali oteklost dihalnih poti med usti, nosom in pljuči, bronhitis,
If you forget to take Zejula 
Če ste pozabili vzeti zdravilo Zejula
The recommended starting dose is 3 capsules taken together once a day (total daily dose of 300 mg), with or without food. 
Priporočeni začetni odmerek so 3 kapsule, ki jih vzamete naenkrat, in sicer enkrat dnevno (skupni dnevni odmerek 300 mg), s hrano ali brez nje.
• Abnormal blood tests 
• nenormalni rezultati krvnih preiskav.
Your doctor will measure your blood pressure regularly throughout your treatment. 
Med zdravljenjem bo zdravnik redno meril vaš krvni tlak.
Only 13 % of low body weight patients remained at a dose of 300 mg beyond Cycle 3. 
Samo 13 % bolnic z majhno telesno maso je po 3. ciklu še vedno prejemalo odmerek 300 mg.
Testing for tBRCA mutation and homologous recombination deficiency (HRD) was performed using the HRD test on tumour tissue obtained at the time of initial diagnosis or at the time of recurrence. 
Testiranje za mutacije tBRCA in pomanjkljivosti homologne rekombinacije (HRD) so izvedli s testom HRD na tumornih tkivih, odvzetih ob času prvotne diagnoze ali ob času relapsa.
The European Medicines Agency has waived the obligation to submit the results of studies with Zejula in all subsets of the paediatric population in ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Zejula za vse podskupine pediatrične populacije pri karcinomu jajčnika (izvzeti so rabdomiosarkom in tumorji germinalnih celic).
Aclar/PVC/aluminium foil perforated unit dose blisters in cartons of 84 × 1, 56 × 1 and 28 × 1 hard capsules. 
Perforirani pretisni omoti iz Aclar/PVC/aluminijaste folije, deljivi na posamezne odmerke, v škatlah s 84 × 1, 56 × 1 in 28 × 1 trdo kapsulo
If further dose reduction is needed, a second dose reduction from two hard capsules daily (200 mg) to one capsule daily (100 mg) may be implemented. 
Če je potrebno nadaljnje zmanjšanje odmerka, je mogoče odmerek zmanjšati z dveh trdih kapsul dnevno (200 mg) na eno kapsulo dnevno (100 mg).
Patient-reported outcome (PRO) data from validated survey tools (FOSI and EQ-5D) indicate that niraparib-treated patients reported no difference from placebo in measures associated with quality of life (QoL). 
Podatki o izidih, ki so jih poročale bolnice (PRO - patient-reported outcome), pridobljeni s potrjenimi raziskovalnimi orodji (FOSI in EQ5D), kažejo, da bolnice, zdravljene z niraparibom, niso poročale o razlikah v primerjavi s placebom pri merilih, povezanih s kakovostjo življenja (QoL - quality of life).
The systemic exposures (Cmax and AUC) to niraparib increased in a dose-proportional manner when the dose of niraparib increased from 30 mg to 400 mg. 
Sistemske izpostavljenosti (Cmax in AUC) niraparibu so se pri povečevanju odmerka nirapariba od 30 mg do 400 mg povečevale v sorazmerju z odmerkom.
• If platelet count is < 75,000/μL at any time, resume at a reduced dose. 
Če je število trombocitov kadar koli < 75.000/μl, ponovno začnite zdravljenje z zmanjšanim odmerkom.
• Swelling in the feet, ankles, legs, and/or hands 
• otekanje stopal, gležnjev, nog in/ali dlani,
M1 is not a CYP1A2 inducer. 
M1 ni induktorCYP1A2.
Patients could not have received prior PARP inhibitor therapy, including Zejula. 
Bolnice niso smele prejeti predhodnega zdravljenja z zaviralci PARP, vključno z zdravilom Zejula.
The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg. 
Odmerek so tri 100 mg trde kapsule enkrat dnevno, kar ustreza skupnemu dnevnemu odmerku 300 mg.
Carcinogenicity studies have not been conducted with niraparib. 
Študije karcinogenosti z niraparibom niso bile izvedene.
Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) including clinical diagnoses and/or laboratory findings generally occurred early during niraparib treatment with the incidence decreasing over time. 
Hematološki neželeni učinki (trombocitopenija, anemija, nevtropenija), vključno s kliničnimi diagnozami in/ali laboratorijskimi izvidi, so se na splošno pojavljali zgodaj med zdravljenjem s niraparibom, njihova pojavnost pa je s časom upadala.
Niraparib is not a substrate of bile salt export pump (BSEP). 
Niraparib ni substrat eksportne črpalke žolčnih soli (BSEP, bile salt export pump).
If you are breast-feeding, you must stop before you start taking Zejula and you must not begin breast-feeding again until 1 month after taking your last dose. 
Če dojite, morate prenehati z dojenjem, preden začnete jemati zdravilo Zejula, in ne smete ponovno dojiti, dokler ne preteče 1 mesec od tega, ko ste vzeli svoj zadnji odmerek.
Animal reproductive and developmental toxicity studies have not been conducted. 
Študije vpliva na sposobnost razmnoževanja in razvoj na živalih niso bile izvedene.
Zejula hard capsules contain lactose monohydrate. 
Laktoza Trde kapsule zdravila Zejula vsebujejo laktozo monohidrat.
The capsules contain a white to off-white powder. 
Kapsule vsebujejo bel do umazano bel prašek.
In repeat-dose oral toxicity studies, niraparib was administered daily for up to 3 months' duration in rats and dogs. 
V študijah peroralne toksičnosti pri ponovljenih odmerkih so niraparib do 3 mesece vsak dan dajali podganam in psom.
Capsule shell Titanium dioxide (E 171) Gelatin 
Ovojnica kapsule titanov dioksid (E 171)
In the population pharmacokinetic analysis of data from clinical studies in patients, pre-existing mild (CLCr < 90 - ≥ 60 ml/min) and moderate (CLCr < 60 - ≥ 30 mL/min) renal impairment did not influence the clearance of niraparib. 
V analizi populacijske farmakokinetike podatkov iz kliničnih študij pri bolnicah predhodno obstoječa blaga (CLCr < 90 - ≥ 60 ml/min) in zmerna (CLCr < 60 - ≥ 30 ml/min) okvara ledvic ni vplivala na očistek nirapariba.
(20.3-NR) 
(20,3-ND)
If adverse reactions are not manageable with this strategy of dose interruption and reduction, it is recommended that Zejula be discontinued. 
Če neželenih učinkov ni mogoče obvladati z opisano strategijo prekinitev odmerjanja in zmanjševanja odmerka, je priporočljivo zdravljenje z zdravilom Zejula ukiniti.
Table 4 shows the results for the PFS primary endpoint for the primary efficacy populations (gBRCAmut cohort and the overall non-gBRCAmut cohort). 
V preglednici 4 so prikazani rezultati za primarni opazovani dogodek PFS pri populacijah za oceno primarne učinkovitosti (kohorta gBRCAmut in celotna kohorta ne-gBRCAmut).
Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased 
Pogosti zvišana gama-glutamil transferaza, zvišana AST, zvišan kreatinin v krvi, zvišana ALT, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
• The active substance is niraparib. 
• Učinkovina je niraparib.
A pregnancy test should be performed on all women of childbearing potential prior to treatment. 
Pred zdravljenjem je treba pri vseh ženskah v rodni dobi narediti test nosečnosti.
It is therefore recommended to monitor complete blood counts (CBCs) weekly during the first month of treatment and modify the dose as needed. 
Zato je priporočljivo, da prvi mesec zdravljenja vsak teden spremljate celotno krvno sliko (CKS) in po potrebi prilagodite odmerek.
Paediatric population No studies have been conducted in paediatric patients. 
Pediatrična populacija Študij pri pediatričnih bolnicah niso izvedli.
The pharmacokinetics of niraparib have not been assessed in patients with severe hepatic impairment (see section 4.2). 
Farmakokinetike nirapariba niso ocenili pri bolnicah s hudo okvaro jeter (glejte poglavje 4.2).
In the case that the adverse reaction recurs, it is recommended to reduce the dose. 
Če se neželeni učinek ponovi, je odmerek priporočljivo zmanjšati.
Niraparib is metabolised primarily by carboxylesterases (CEs) to form a major inactive metabolite, M1. 
Niraparib primarno presnavljajo karboksilesteraze (CE), pri čemer nastaja glavni neaktivni presnovek, M1.
In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib was 16.2 L/h in cancer patients. 
V analizi populacijske farmakokinetike je bil navidezni celotni očistek (CL/F) nirapariba pri bolnicah z rakom 16,2 l/h.
Following multiple oral doses of niraparib from 30 mg to 400 mg once daily, accumulation of niraparib was approximately 2 to 3 folds. 
Po večkratnih peroralnih odmerkih od 30 mg do 400 mg nirapariba enkrat dnevno je bilo kopičenje nirapariba približno 2- do 3-kratno.
Frequency of all CTCAE grades 
Pogostnost vseh stopenj po
In vitro, niraparib weakly induces CYP1A2 at high concentrations and the clinical relevance of this effect would not be completely ruled out. 
Niraparib in vitro v visokih koncentracijah šibko inducira CYP1A2 in kliničnega pomena tega ni mogoče povsem izključiti.
• Feelings of sadness, depressed 
• občutek žalosti, depresivnosti,
In vitro, niraparib inhibited the dopamine transporter DAT at concentration levels below human exposure levels. 
Niraparib je in vitro zaviral dopaminski prenašalec DAT pri koncentracijah, nižjih od ravni izpostavljenosti pri človeku.
In a population pharmacokinetic analysis of niraparib, the Vd/F was 1,074 L in cancer patients, indicating extensive tissue distribution of niraparib. 
V analizi populacijske farmakokinetike nirapariba je bil Vd/F pri bolnicah z rakom 1,074 l, kar kaže na obsežno porazdelitev nirapariba po tkivih.
In the NOVA study, patients eligible for Zejula therapy had the following baseline haematologic parameters: absolute neutrophil count (ANC) ≥ 1,500 cells/µL; platelets ≥ 100,000 cells/µL and haemoglobin ≥ 9 g/dL prior to therapy. 
V študiji NOVA so bolnice, primerne za zdravljenje z zdravilom Zejula, imele naslednje izhodiščne hematološke parametre: absolutno število nevtrofilcev (ANC, absolute neutrophil count) ≥ 1,500 celic/µl; trombociti ≥ 100.000 celic/µl in hemoglobin ≥ 9 g/dl pred zdravljenjem.
The secondary endpoints CFI, TFST, and PFS2 demonstrated a statistically significant and persistent treatment effect in favour of the niraparib treatment arm in the gBRCAmut cohort and the overall non-gBRCAmut cohort (Table 5). 
Sekundarni opazovani dogodki CFI, TFST in PFS2 so pokazali statistično značilen in dolgotrajen učinek zdravljenja v korist kraka zdravljenja z niraparibom v kohorti gBRCAmut in celotni kohorti ne-gBRCAmut (preglednica 5).
• Fast heart beat may cause dizziness, chest pain or breathlessness 
• hitro bitje srca lahko povzroči omotičnost, bolečino v prsih ali pomanjkanje sape,
Your doctor will ask you to confirm that you are not pregnant with a pregnancy test before starting your treatment. 
Pred začetkom zdravljenja vas bo zdravnik prosil, da s testom nosečnosti potrdite, da niste noseči.
After the first month, it is recommended to monitor CBCs monthly and periodically after this time (see section 4.4). 
Po prvem mesecu je priporočljivo vsakomesečno spremljanje CKS, po tem pa periodično (glejte poglavje 4.4).
A possible cause for sepsis is a low neutrophil count and there is a potential association between niraparib and developing sepsis. 
Možen vzrok sepse je majhno število nevtrofilcev, zato obstaja možna povezava med niraparibom in razvojem sepse.
What you need to know before you take Zejula Do not take Zejula 
Kaj morate vedeti, preden boste vzeli zdravilo Zejula Ne jemljite zdravila Zejula
Patients treated with Zejula who develop thrombocytopenia might have an increased risk of haemorrhage. 
Bolnice, zdravljene z zdravilom Zejula, pri katerih se razvije trombocitopenija, so lahko izpostavljene višjemu tveganju krvavitve.
(12.9, NR) 
(12,9, ND)
• Bruising or bleeding for longer than usual if you hurt yourself -- these may be signs of a low blood platelet count (thrombocytopenia). 
• Modrica ali krvavitev, ki je prisotna dlje kot običajno, če se poškodujete - to je lahko znak nizkega števila krvnih ploščic (trombocitopenija).
Blood pressure should be monitored monthly for the first year and periodically thereafter during treatment with Zejula. 
Med zdravljenjem z zdravilom Zejula je treba prvo leto spremljati krvni tlak enkrat mesečno, nato pa periodično.
(17.5-NR) 
(17,5-ND)
Niraparib is an inhibitor of MATE1 and -2 with IC50 of 0.18 µM and ≤ 0.14 µM, respectively. 
Niraparib je zaviralec MATE1 in MATE2 z IC50 0,18 µM oziroma ≤ 0,14 µM.
84 × 1 hard capsules 56 × 1 hard capsules 28 × 1 hard capsules 
84 × 1 trda kapsula 56 × 1 trda kapsula 28 × 1 trda kapsula
Breast-feeding is contraindicated during administration of Zejula and for 1 month after receiving the last dose (see section 4.3). 
Dojenje je kontraindicirano med dajanjem zdravila Zejula in še 1 mesec po prejemu zadnjega odmerka (glejte poglavje 4.3).
What Zejula looks like and contents of the pack 
Izgled zdravila Zejula in vsebina pakiranja
To be eligible for niraparib treatment, the patient should be in response (CR or PR) following completion of last platinum based chemotherapy. 
Da so bile primerne za zdravljenje z niraparibom, so bolnice morale imeti odziv (PO ali DO) po zaključku zadnje kemoterapije na osnovi platine.
• The other ingredients (excipients) are: capsule content: magnesium stearate, lactose monohydrate capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), erythrosine (E 127), tartrazine (E 102) printing ink: shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), black iron oxide (E 172), sodium hydroxide (E 524), and povidone (E 1201). 
• Druge sestavine zdravila (pomožne snovi) so: vsebina kapsule: magnezijev stearat, laktoza monohidrat; ovojnica kapsule: titanov dioksid (E 171), želatina, barvilo modro FCF (E 133), eritrozin (E 127), tartrazin (E 102); tiskarsko črnilo: šelak (E 904), propilenglikol (E 1520), kalijev hidroksid (E 525), črni železov oksid (E 172), natrijev hidroksid (E 524) in povidon (E 1201).
A concomitant high-fat meal did not significantly affect the pharmacokinetics of niraparib after administration of 300 mg of niraparib. 
Sočasen obrok z veliko maščobe ni znatno vplival na farmakokinetiko nirapariba po dajanju 300 mg nirapariba.
Table 4: Summary of primary objective outcomes in the ENGOT-OV16 study gBRCAmut cohort 
Preglednica 4: Povzetek izidov primarnega cilja v študiji ENGOT-OV16 Kohorta gBRCAmut Kohorta ne-gBRCAmut niraparib
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih vrst sladkorja, se pred jemanjem tega zdravila posvetujte z njim.
Inhibition of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) Neither niraparib nor M1 is an inhibitor of any active substance-metabolising CYP enzymes, namely CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5. 
Zaviranje CYP (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4) Niraparib in M1 nista zaviralca nobenega encima CYP, ki sodeluje pri presnovi učinkovin, torej CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4/5.
bronchitis 
bronhitis
• For patients with platelet count ≤ 10,000/μL, platelet transfusion should be considered. 
Pri bolnicah s številom trombocitov ≤ 10.000/μl je treba razmisliti o transfuziji trombocitov.
Oedema peripheral 
Pogosti periferni edem
Some of the patients had a history of bone marrow dysplasia. 
Nekatere bolnice so imele anamnezo displazije kostnega mozga.
In pooled samples collected over 6 days, 40.0 % of the dose was recovered in the urine primarily as metabolites and 31.6 % of the dose was recovered in the feces primarily as unchanged niraparib. 
Iz združenih vzorcev, zbranih v 6 dneh, je bilo iz urina pridobljenega 40,0 % odmerka primarno v obliki presnovkov, 31,6 % odmerka pa je bilo pridobljenega iz blata,
Patients who take Zejula may experience asthenia, fatigue and dizziness. 
Pri bolnicah, ki jemljejo zdravilo Zejula, se lahko pojavijo astenija, utrujenost in omotičnost.