natgillin/translations-raw huggingface dataset:
In mice, single doses of niraparib increased intracellular levels of dopamine and metabolites in cortex. 
Pri miših so enkratni odmerki nirapariba zvišali medcelične ravni dopamina in presnovkov v korteksu.
• Elevated blood tests 
• zvišani rezultati krvnih preiskav,
• Resume Zejula at same or reduced dose based on clinical evaluation. 
Ponovno začnite zdravljenje z zdravilom Zejula z enakim ali zmanjšanim odmerkom, skladno s klinično presojo.
Figure 1: Kaplan-Meier plot for progression-free survival in the gBRCAmut cohort based on IRC assessment (ITT population, N = 203) 
Slika 1: Kaplan-Meierjev grafikon za preživetje brez napredovanja bolezni v kohorti gBRCAmut na osnovi ocene IRC (populacija ITT, N = 203)
The major primary metabolite M1 is not a substrate of P-gp, BCRP, or BSEP. 
Glavni primarni presnovek M1 ni substrat P-gp, BCRP ali BSEP.
Zejula should not be used during pregnancy. 
Zdravila Zejula ne smete uporabljati pri nosečnicah.
There are no or limited amount of data from the use of niraparib in pregnant women. 
Podatkov o uporabi nirapariba pri nosečnicah ni oziroma so omejeni.
Do not take an additional dose if you miss a dose or vomit after taking Zejula. 
Ne vzemite dodatnega odmerka, če ste pozabili vzeti prejšnji odmerek ali če ste bruhali po jemanju zdravila Zejula.
Non-haematologic CTCAE* ≥ Grade 3 treatment-related adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment 
Preglednica 1: Prilagajanje odmerka zaradi nehematoloških neželenih učinkov Z zdravljenjem povezan nehematološki neželeni učinek stopnje ≥ 3 po CTCAE*, pri katerem se smatra, da profilaksa ni možna ali pa neželeni učinek ostane kljub zdravljenju
If patients miss a dose, they should take their next dose at its regularly scheduled time. 
Izpuščeni odmerek Če bolnica izpusti odmerek, naj vzame svoj naslednji odmerek ob naslednjem času skladno z načrtom jemanja zdravila.
Reduced locomotor activity was seen in one of two single dose studies in mice. 
V eni od dveh študij z enkratnim odmerkom pri miših so opazili zmanjšano lokomotorično aktivnost.
Your doctor will test your blood regularly throughout your treatment. 
Med zdravljenjem bo zdravnik redno izvajal preiskave vaše kri.
• 84 × 1 hard capsules 
• 84 × 1 trdo kapsulo
Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair. 
Niraparib je zaviralec poli-(ADP-riboza) polimeraz (PARP), in sicer PARP1 in PARP2, ki imata vlogo pri popravljanju poškodb DNA.
The rate of new incidences of thrombocytopenia after intensive dose modifications were performed during the first two months of treatment from Cycle 4 was 1.2 %. 
Stopnja novih incidenc trombocitopenije po intenzivnih prilagajanjih odmerkov, ki so bila izvedena v prvih dveh mesecih zdravljenja od
Following a single-dose administration of 300 mg niraparib under fasting conditions, niraparib was measurable in plasma within 30 minutes and the mean peak plasma concentration (Cmax) for niraparib was reached in about 3 hours [804 ng/mL (% CV:50.2 %)]. 
Po dajanju enkratnega odmerka 300 mg nirapariba na tešče je bil niraparib v 30 minutah merljiv v plazmi, povprečna najvišja plazemska koncentracija (Cmax) za niraparib pa je bila dosežena v približno 3 urah [804 ng/ml (% CV: 50,2 %)].
In the NOVA study, 48 of 367 (13 %) of patients experienced bleeding with concurrent thrombocytopenia; all bleeding events concurrent with thrombocytopenia were Grade 1 or 2 in severity except for one event of Grade 3 petechiae and haematoma observed concurrently with a serious adverse event of pancytopenia. 
V študiji NOVA se je pri 48 od 367 (13 %) bolnic pojavila krvavitev s sočasno trombocitopenijo; vsi dogodki krvavitev s sočasno trombocitopenijo so bili stopnje resnosti 1 ali 2, z izjemo enega dogodka petehij in hematoma 3. stopnje, opaženega sočasno z resnim neželenim učinkom pancitopenijo.
Table 3: Adverse drug reactions: frequencies based on all-causality adverse events* System Organ Class 
Preglednica 3: Neželeni učinki zdravila: pogostnosti na osnovi neželenih dogodkov vseh vzrokov*
When you are taking Zejula it may make you feel weak, tired or dizzy and therefore influence your ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ko jemljete zdravilo Zejula, lahko to pri vas povzroči občutek slabotnosti, utrujenosti ali omotičnosti in s tem vpliva na vašo sposobnost vožnje in upravljanja strojev.
Paediatric population No studies have been conducted to investigate the pharmacokinetics of niraparib in paediatric patients. 
Pediatrična populacija Študije za raziskavo farmakokinetike nirapariba pri pediatričnih bolnicah niso bile izvedene.
Median ages ranged from 57 to 63 years across treatments and cohorts. 
Mediane starosti so se v skupinah zdravljenja in kohortah gibale od 57 to 63 let.
Hard capsule of approximately 22 mm × 8 mm; white body with “100 mg” printed in black ink and purple cap with “Niraparib” printed in white ink. 
Trda kapsula z merami približno 22 mm × 8 mm; belo telo z napisom »100 mg«, odtisnjenim s črnim črnilom, in vijoličast pokrovček z napisom »Niraparib«, odtisnjenim z belim črnilom.
Neither niraparib nor M1 is a CYP3A4 inducer in vitro. 
Niraparib in M1 in vitro nista induktorja CYP3A4.
Second occurrence: 
Drugi pojav:
Median (95 % CI) - mo 
Mediani (95-% IZ) - mo
Figure 2: Kaplan-Meier plot for progression-free survival in the non-gBRCAmut cohort overall based on IRC assessment (ITT population, N = 350) 
Slika 2: Kaplan-Meierjev grafikon za preživetje brez napredovanja bolezni v celotni kohorti ne-gBRCAmut na osnovi ocene IRC (populacija ITT, N = 350)
In vitro, niraparib weakly inhibits the organic cation transporter 1 (OCT1) with an IC50 = 34.4 µM. 
Niraparib in vitro šibko zavira organski kationski prenašalec 1 (OCT1) z IC50 = 34,4 µM.
Taking Zejula at bedtime may help you to manage nausea. 
Če zdravilo Zejula jemljete pred spanjem, vam to lahko pomaga obvladati siljenje na bruhanje.
Zejula should not be used during pregnancy or in women of childbearing potential not willing to use reliable contraception during therapy and for 1 month after receiving the last dose of Zejula (see section 4.6). 
Zdravila Zejula ne smete uporabljati pri nosečnicah ali ženskah v rodni dobi, ki med zdravljenjem in še 1 mesec po prejemu zadnjega odmerka zdravila Zejula niso pripravljene uporabljati zanesljive kontracepcije (glejte poglavje 4.6).
Approximately 50 % of patients experienced anaemia of any grade, and 25 % experienced Grade 3/4 anaemia. 
Pri približno 50 % bolnic se je pojavila anemija katere koli stopnje, pri 25 % bolnic pa se je pojavila anemija 3. ali 4. stopnje.
Discontinuation due to thrombocytopenia events (thrombocytopenia and platelet count decreased) occurred in approximately 3 % of the patients. 
Do ukinitve zdravljenja zaradi dogodkov trombocitopenije (trombocitopenije in znižanega števila trombocitov) je prišlo pri približno 3 % bolnic.
Caution is recommended when niraparib is combined with active substances that undergo an uptake transport by OCT1 such as metformin. 
Pri kombiniranju nirapariba z učinkovinami, ki so podvržene privzemnemu prenosu z OCT1, kot je na primer metformin.
Thrombocytopenia occurred more commonly in patients whose baseline platelet count was less than 180 × 109/L. 
Trombocitopenija se je pogosteje pojavila pri bolnicah z izhodiščnim številom trombocitov manj kot 180 × 109/l.
Chemotherapy-free interval Median (95 % CI) - mo 
Interval brez kemoterapije Mediani (95-% IZ) - mo
• Discontinue Zejula if neutrophils and/or haemoglobin have not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD. 
Ukinite zdravljenje z zdravilom Zejula, če se število nevtrofilcev in/ali raven hemoglobina ne povrne na sprejemljivo raven v 28-dnevnem obdobju prekinitve odmerjanja ali če je odmerek, ki ga prejema bolnica, že bil zmanjšan na 100 mg enkrat dnevno.
Haematologic adverse reaction requiring transfusion or haematopoietic growth factor support 
zaradi katerih je potrebna podpora s transfuzijo ali hematopoetskimi rastnimi faktorji
Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. 
Zdravilo Zejula je indicirano kot monoterapija za vzdrževalno zdravljenje pri odraslih bolnicah z relapsom na platino občutljivega seroznega epitelijskega karcinoma jajčnika, jajcevoda ali primarnega peritonealnega karcinoma visoke stopnje, ki se (delno ali v celoti) odzivajo na kemoterapijo na osnovi platine.
Approximately 76 % of patients with lower baseline platelets (< 180 × 109/L) who received Zejula experienced thrombocytopenia of any grade, and 45 % of the patients experienced Grade 3/4 thrombocytopenia. 
Pri približno 76 % bolnic z nižjim izhodiščnim številom trombocitov (< 180 × 109/l), ki so prejele zdravilo Zejula, se je pojavila trombocitopenija katere koli stopnje, pri 45 % bolnic pa se je pojavila trombocitopenija stopnje 3/4.
In addition, Granulocyte-Colony Stimulating Factor (G-CSF) was administered to approximately 6 % of patients treated with niraparib as concomitant therapy for neutropenia. 
Poleg tega je približno 6 % bolnic, zdravljenih z niraparibom, prejelo rastne faktorje granulocitne vrste (G-CSF) kot sočasno terapijo za nevtropenijo.
Talk to your doctor, pharmacist or nurse before or while taking this medicine if any of the following could apply to you: 
Pred začetkom jemanja ali med jemanjem tega zdravila se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če bi za vas lahko veljalo kar koli od naslednjega:
More patients in the niraparib group continued treatment for more than 12 months than patients in the placebo group (34.2 % and 21.1 %, respectively). 
Več bolnic v skupini z niraparibom kot v skupini s placebom je nadaljevalo zdravljenje več kot 12 mesecev (34,2 % oziroma 21,1 %).
Caution is then recommended when niraparib is combined with substrates of BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin, and methotrexate). 
Zato je priporočljiva previdnost pri kombiniranju nirapariba s substrati BCRP (irinotekan, rosuvastatin, simvastatin,
(17.9-NR) 
(17,9-ND)
Platelet count < 100,000/μL 
Število trombocitov < 100.000/μl
Zejula can be taken without regard to meals. 
Zdravilo Zejula je mogoče jemati s hrano ali brez nje.
Niraparib as a substrate of efflux transporters (P-gp, BCRP, and MATE1/2) Niraparib is a substrate of P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP). 
Niraparib kot substrat izločevalnih prenašalcev (P-gp, BCRP in MATE 1/2) Niraparib je substrat P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP, Breast
What Zejula is and what it is used for What Zejula is and how it works 
Kaj je zdravilo Zejula in kako deluje
Due to the risk of thrombocytopenia, anticoagulants and medicinal products known to reduce the thrombocyte count should be used with caution (see section 4.8). 
Zaradi tveganja za trombocitopenijo je potrebna previdnost pri uporabi antikoagulantov in zdravil, za katera je znano, da zmanjšujejo število trombocitov (glejte poglavje 4.8).
Zejula is used in adult women for the treatment of cancer of the ovary, the fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or the peritoneum (the membrane lining the abdomen). 
Zdravilo Zejula se uporablja pri odraslih ženskah za zdravljenje raka jajčnika, jajcevoda (dela ženskih spolnih organov, ki povezuje jajčnike z maternico) ali peritoneja (membrane, ki obdaja trebušno votlino).
Discontinuation due to neutropenia events occurred in 2 % of patients. 
Do ukinitve zdravljenja zaradi dogodkov nevtropenije je prišlo pri 2 % bolnic.
Myelodysplastic syndrome/acute myeloid leukaemia 
Mielodisplastični sindrom/akutna mieloična levkemija
Testing complete blood counts weekly for the first month, followed by monthly monitoring for the next 10 months of treatment and periodically after this time is recommended to monitor for clinically significant changes in any haematologic parameter during treatment (see section 4.2). 
Za spremljanje klinično pomembnih sprememb katerega koli hematološkega parametra med zdravljenjem je priporočljivo vsakotedensko preverjanje celotne krvne slike v prvem mesecu, čemur sledi vsakomesečno spremljanje naslednjih 10 mesecev, za tem pa periodično spremljanje (glejte poglavje 4.2).
Package leaflet: Information for the patient Zejula 100 mg hard capsules niraparib This medicine is subject to additional monitoring. 
Navodilo za uporabo Zejula 100 mg trde kapsule niraparib Za to zdravilo se izvaja dodatno spremljanje varnosti.
Therefore, caution should be taken if niraparib is used in combination with vaccines, immunosuppressant agents or with other cytotoxic medicinal products. 
Zato je pri uporabi nirapariba v kombinaciji s cepivi, imunosupresivi ali drugimi citotoksičnimi zdravili potrebna previdnost.
In the population pharmacokinetic analysis of data from clinical studies in patients, pre-existing mild and moderate hepatic impairment did not influence the clearance of niraparib. 
V analizi populacijske farmakokinetike podatkov iz kliničnih študij pri bolnicah predhodno obstoječa blaga in zmerna okvara jeter ni vplivala na očistek nirapariba.
Inhibition of efflux transporters (P-gp, BCRP, BSEP, and MATE1/2) Niraparib is not an inhibitor of BSEP. 
Zaviranje izločevalnih prenašalcev (P-gp, BCRP, BSEP in MATE 1/2) Niraparib ni zaviralec BSEP.
Increased niraparib-induced cytotoxicity was observed in tumour cell lines with or without deficiencies in the BReast CAncer (BRCA) 1 and 2 tumour suppressor genes. 
Povečano citotoksičnost, ki jo povzroča niraparib, so opazili v tumorskih celičnih linijah z okvarami tumorskih supresorskih genov raka dojke (BRCA, BReast CAncer) 1 in 2 ali brez njih.
PFS median (95% CI*) 
mediano PFS (95-% IZ*)
Table 1: Dose modifications for non-haematologic adverse reactions 
Preglednica 2: Prilagajanje odmerka zaradi hematoloških neželenih učinkov
(13.3-NR) 
(13,3-ND)
In the gBRCAmut cohort, the median number of treatment cycles was higher in the niraparib arm than the placebo arm (14 and 7 cycles, respectively). 
V kohorti gBRCAmut je bilo mediano število ciklov zdravljenja višje v kraku z niraparibom kot v kraku s placebom (14 oziroma 7 ciklov).
Zejula lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia). 
Zdravilo Zejula zniža števila vaših krvnih celic, kot so število rdečih krvničk (anemija), število belih krvničk (nevtropenija) ali število krvnih ploščic (trombocitopenija).
Pre-existing hypertension should be adequately controlled before starting Zejula treatment. 
Pred začetkom zdravljenja z zdravilom Zejula je treba ustrezno obvladati obstoječo hipertenzijo.
The recommended dose reductions are first from three hard capsules daily (300 mg) to two hard capsules daily (200 mg). 
Priporočeno zmanjšanje odmerka je naprej s treh trdih kapsul dnevno (300 mg) na dve trdi kapsuli dnevno (200 mg).
The primary tumour site in most patients (> 80 %) within each cohort was the ovary; most patients (> 84 %) had tumours with serous histology. 
Primarno mesto tumorja pri večini bolnic (> 80 %) v vsaki kohorti je bil jajčnik.
Niraparib was not mutagenic in a bacterial reverse mutation assay (Ames) test but was clastogenic in an in vitro mammalian chromosomal aberration assay and in an in vivo rat bone marrow micronucleus assay. 
Niraparib v preskusu bakterijske reverzne mutacije (Ames) ni bil mutagen, vendar pa je bil klastogen v in vitro preskusu kromosomskih aberacij sesalcev ter v in vivo preskusu mikronukleusov v podganjem kostnem mozgu.
Therefore, caution is recommended when niraparib is combined with active substances the metabolism of which is CYP1A2-dependent and, notably, those having a narrow therapeutic range (e.g. clozapine, theophylline, and ropinirole). 
Zato je priporočljiva previdnost pri kombiniranju nirapariba z učinkovinami, katerih presnova je odvisna od CYP1A2, zlasti tistimi, ki imajo ozek terapevtski razpon (npr. klozapin, teofilin in ropinirol).
CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered Zejula 100 mg/day 
CTCAE, ki je prisoten več kot 28 dni, medtem ko bolnica prejema zdravilo Zejula 100 mg/dan
Therefore, caution is recommended when niraparib is combined with active substances the metabolism of which is CYP3A4-dependent and, notably, those having a narrow therapeutic range (e.g. ciclosporin, tacrolimus, alfentanil, ergotamine, pimozide, quetiapine, and halofantrine). 
Zato je priporočljiva previdnost pri kombiniranju nirapariba z učinkovinami, katerih presnova je odvisna od CYP3A4, zlasti tistimi, ki imajo ozek terapevtski razpon (npr. ciklosporin, takrolimus, alfentanil, ergotamin, pimozid, kvetiapin in halofantrin).
More patients in the niraparib group continued treatment for more than 12 months than patients in the placebo group (54.4 % and 16.9 % respectively). 
Več bolnic iz skupine z niraparibom kot bolnic iz skupine s placebom je nadaljevalo zdravljenje več kot 12 mesecev (54,4 % oziroma 16,9 %).
How to take Zejula 
Kako jemati zdravilo Zejula
Shellac (E 904) Propylene glycol (E 1520) Potassium hydroxide (E 525) Black iron oxide (E 172) Sodium hydroxide (E 524) Povidone (E 1201) 
Tiskarsko črnilo šelak (E 904) propilenglikol (E 1520) kalijev hidroksid (E 525) črni železov oksid (E 172) natrijev hidroksid (E 524) povidon (E 1201)
The following adverse reactions have been identified in the ENGOT-OV16 study in patients receiving Zejula monotherapy (see Table 3). 
V študiji ENGOT-OV16 so pri bolnicah, ki so prejemale monoterapijo z zdravilom Zejula, ugotovili naslednje neželene učinke (glejte preglednico 3).
Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Zejula dose (see section 4.2), if necessary. 
Hipertenzijo je treba medicinsko obvladati z zdravili proti hipertenziji in po potrebi tudi prilagoditvijo odmerka zdravila Zejula (glejte poglavje 4.2).
In vitro, niraparib inhibits P-gp very weakly and BCRP with an IC50 = 161 µM and 5.8 µM, respectively. 
Niraparib in vitro zavira BCRP in zelo šibko zavira P-gp, z IC50 = 5,8 µM oziroma 161 µM.
Following a single oral 300-mg dose of niraparib, the mean terminal half-life (t½) of niraparib ranged from 48 to 51 hours (approximately 2 days). 
Po enkratnem peroralnem odmerku 300 mg nirapariba se je povprečni terminalni razpolovni čas (t½) nirapariba gibal od 48 do 51 ur (približno 2 dni).
In the overall non-gBRCAmut cohort, the median number of treatment cycles was higher in the niraparib arm than in the placebo arm (8 and 5 cycles, respectively). 
V celotni kohorti ne-gBRCAmut je bilo mediano število ciklov zdravljenja višje v kraku z niraparibom kot v kraku s placebom (8 oziroma 5 ciklov).
• Resume Zejula at a reduced dose (100 mg/day). 
• Ponovno začnite zdravljenje z zdravilom Zejula z zmanjšanim odmerkom (100 mg/dan).
Within each cohort, patients were randomised using a 2:1 allocation of niraparib and placebo. 
V vsaki kohorti so bile bolnice randomizirane v skupino z niraparibom ali placebom v razmerju 2 : 1.
In most cases, hypertension was controlled adequately using standard antihypertensive treatment with or without Zejula dose adjustment (see section 4.2). 
V večini primerov je bila hipertenzija zadostno obvladana s standardnim zdravljenjem proti hipertenziji ob zmanjšanju odmerka ali brez zmanjšanja odmerka zdravila Zejula (glejte poglavje 4.2).
In orthotopic high-grade serous ovarian cancer patient-derived xenograft tumours (PDX) grown in mice, niraparib has been shown to reduce tumour growth in BRCA 1 and 2 mutant, BRCA wild-type but homologous recombination (HR) deficient, and in tumours that are BRCA wild-type and without detectable HR deficiency. 
Na ksenotransplantiranih tumorjih, pridobljenih iz bolnic z ortotopskim seroznim rakom jajčnika visoke stopnje (PDX, patient-derived xenograft tumours), ki so jih gojili na miših, so za niraparib dokazali, da zmanjšuje rast tumorjev pri mutiranem BRCA 1 in 2, BRCA divjega tipa s pomanjkanjem homologne rekombinacije (HR) in pri tumorjih divjega tipa BRCA brez zaznavnega pomanjkanja HR.
There are no data in patients with severe hepatic impairment; use with caution in these patients (see section 5.2). 
Podatkov za bolnice s hudo okvaro jeter ni; pri teh bolnicah zdravilo uporabljajte previdno (glejte poglavje 5.2).
Discontinuation due to anaemia occurred in 1 % of patients. 
Do ukinitve zdravljenja zaradi anemije je prišlo pri 1 % bolnic.
In the HRDneg group, the hazard ratio was 0.58 (95 % CI, 0.361, 0.922; p = 0.0226). 
V skupini, negativni za HRD, je bilo razmerje tveganja 0,58 (95-% IZ, 0,361, 0,922; p = 0,0226).
Taking into account the PRAC Assessment Report on the PSUR(s) for niraparib, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za niraparib je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
The major primary metabolite M1 does not appear to be an inhibitor of P-gp, BCRP, BSEP, or MATE1/2. 
Za glavni primarni presnovek M1 kaže, da ni zaviralec P-gp, BCRP, BSEP ali MATE 1/2.
Following an oral administration of a single 300-mg dose of [14C]-niraparib, on average 86.2 % (range 71 % to 91 %) of the dose was recovered in urine and feces over 21 days. 
Po peroralnem dajanju enkratnega odmerka 300 mg [14C]nirapariba je bilo v 21 dneh iz urina in blata v povprečju pridobljenega 86,2 % (razpon od 71 % do 91 %) odmerka.
Anaemia of any grade might persist during Zejula treatment. 
Med zdravljenjem z zdravilom Zejula je lahko anemija katere koli stopnje dolgotrajna.
Diarrhoea, constipation, mucosal inflammation (including mucositis), stomatitis, dry mouth 
Občasni driska, zaprtje, vnetje sluznic (vključno z mukozitisom), stomatitis, suha usta
Also contains lactose and tartrazine (E 102). 
SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo in tartrazin (E 102).
• Resume Zejula at a reduced dose (200 mg/day). 
• Ponovno začnite zdravljenje z zdravilom Zejula z zmanjšanim odmerkom (200 mg/dan).
Population pharmacokinetic analyses indicated that age, weight and race had no significant impact on the pharmacokinetics of niraparib. 
Starost, telesna masa in rasa Analize populacijske farmakokinetike kažejo, da starost, telesna masa in rasa nimajo znatnega vpliva na farmakokinetiko nirapariba.
The white opaque capsule body is printed with ‘100 mg' in black ink, and the purple capsule cap is printed with ‘Niraparib' in white ink. 
Na belem neprosojnem telesu kapsule je s črnim črnilom natisnjen napis »100 mg«, na vijoličastem pokrovčku kapsule pa je z belim črnilom natisnjen napis »Niraparib«.
(Nir:plac) (95 % CI*) * CI denotes confidence interval. 
(nir : plac) (95-% IZ*)
Zejula hard capsules have a white opaque body and a purple opaque cap. 
Zdravilo Zejula trde kapsule imajo belo neprosojno telo in vijoličast neprosojen pokrovček.
The experimental test was not able to discriminate which patients would or would not benefit from niraparib maintenance therapy. 
Eksperimentalni test ni mogel ločevati med bolnicami, ki bodo imele korist od vzdrževalnega zdravljenja z niraparibom, in tistimi, ki je ne bodo imele.
However, based on its mechanism of action, niraparib could cause embryonic or foetal harm, including embryo-lethal and teratogenic effects, when administered to a pregnant woman. 
Vendar bi lahko niraparib pri dajanju nosečnicam zaradi svojega mehanizma delovanja imel škodljiv učinek na zarodek ali plod, vključno s smrtjo zarodka in teratogenimi učinki.
Women of childbearing potential must use effective contraception during therapy and for 1 month after receiving the last dose of Zejula. 
Ženske v rodni dobi morajo med zdravljenjem in še 1 mesec po prejemu zadnjega odmerka zdravila Zejula uporabljati učinkovito kontracepcijo.