natgillin/translations-raw huggingface dataset:
Most patients were age 18 to 64 years (78 %), Caucasian (86 %) and had an ECOG performance status of 0 (68 %).
Većina bolesnika bila je u dobi od 18 do 64 godine (78 %), bili su bijelci (86 %) i imali su funkcionalni status 0 prema ECOG ljestvici (68 %).
Anaemia of any grade might persist during Zejula treatment.
Anemija bilo kojeg stupnja može perzistirati tijekom liječenja lijekom Zejula.
Missing dose
Propuštena doza
What Zejula is used for
Za što se Zejula koristi
Treatment with Zejula should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Liječenje lijekom Zejula treba započeti i nadzirati liječnik s iskustvom u primjeni antineoplastičkih lijekova.
• Feeling of worry, nervousness, or unease
• osjećaj zabrinutosti, nervoze ili nelagode
If you forget to take Zejula
Ako ste zaboravili uzeti lijek Zejula
If there are other risk factors for bleeding such as co-administration of anticoagulation or antiplatelet medicinal products, consider interrupting these substances and/or transfusion at a higher platelet count.
Ako su prisutni i drugi rizični čimbenici za krvarenje, kao što je istodobna primjena antikoagulansa ili antitrombocitnih lijekova, razmotrite privremeni prekid primjene tih lijekova i/ili transfuziju pri većem broju trombocita.
In the clinical programme, hypertension was readily managed with anti-hypertensive medicinal products.
U kliničkom programu hipertenzija je bila lako zbrinuta antihipertenzivnim lijekovima.
• Feeling of weakness
• osjećaj slabosti
What Zejula is and what it is used for What you need to know before you take Zejula How to take Zejula
Što je Zejula i za što se koristi Što morate znati prije nego počnete uzimati lijek Zejula Kako uzimati lijek Zejula
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.
Međutim, temeljeno na njegovom mehanizmu djelovanja, niraparib bi, primjenjen u trudnica, mogao uzrokovati embrionalna ili fetalna oštećenja, uključujući embrioletalne i teratogene učinke.
• Inflammation or swelling of the air passages between the mouth and nose and the lungs,
• upalu ili oticanje dišnih puteva između usta i nosa i pluća, bronhitis
The most commonly used dose in niraparib-treated patients in the NOVA study was 200 mg.
Najčešće primjenjivana doza u bolesnika liječenih niraparibom u ispitivanju NOVA bila je 200 mg.
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.
Sistemska izloženost (Cmax i AUC) niraparibu porasla je proporcionalno dozi kada je doza nirapariba povećana s 30 mg na 400 mg.
The primary tumour site in most patients (> 80 %) within each cohort was the ovary; most patients (> 84 %) had tumours with serous histology.
Mjesto primarnog tumora u većine je bolesnika (> 80 %) u svakoj skupini bio jajnik; većina bolesnika (> 84 %) imala je, histološki gledano, serozni tumor.
M1 is not a CYP1A2 inducer.
M1 nije induktor CYP1A2.
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.
U pivotalnom ispitivanju ENGOT-OV16 nuspojave koje su se javile u ≤ 10 % bolesnika koji su primali lijek Zejula u monoterapiji bile su mučnina, trombocitopenija, umor/astenija, anemija, konstipacija, povraćanje, abdominalna bol, neutropenija, nesanica, glavobolja, smanjen apetit, nazofaringitis, proljev, dispneja, hipertenzija, dispepsija, bol u leđima, omaglica, kašalj, infekcije mokraćnog sustava, artralgija, palpitacije i disgeuzija.
In repeat-dose oral toxicity studies, niraparib was administered daily for up to 3 months' duration in rats and dogs.
U ispitivanjima toksičnosti ponovljenih doza primijenjenih peroralno, niraparib se primjenjivao svakodnevno u trajanju do 3 mjeseca u štakora i pasa.
Table 3: Adverse drug reactions: frequencies based on all-causality adverse events* System Organ Class
Tablica 3: Nuspojave lijeka: učestalosti temeljene na štetnim događajima bilo kojeg uzroka* Organski sustav
Febrile neutropenia was reported in 2 out of 367 patients in the NOVA trial leading to the frequency uncommon.
Febrilna neutropenija zabilježena je u 2 od 367 slučajeva u ispitivanju NOVA, čime se svrstava u učestalost „manje često“.
Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine.
Znakovi mogu uključivati vrućicu, zimicu, osjećaj slabosti ili zbunjenosti, kašalj, bol ili osjećaj pečenja prilikom mokrenja.
To be eligible for niraparib treatment, the patient should be in response (CR or PR) following completion of last platinum based chemotherapy.
Kako bi bili pogodni za liječenje niraparibom bolesnici su morali biti u odgovoru (CR ili PR) nakon završetka posljednje kemoterapije koja je sadržavala platinu.
Population pharmacokinetic analyses indicated that age, weight and race had no significant impact on the pharmacokinetics of niraparib.
Analize populacijske farmakokinetike pokazale su da dob, tjelesna težina i rasa nemaju značajan učinak na farmakokinetiku nirapariba.
The experimental test was not able to discriminate which patients would or would not benefit from niraparib maintenance therapy.
Eksperimentalnim testom se nije moglo razlučiti koji bi bolesnici mogli imati koristi od terapije održavanja niraparibom, a koji ne.
PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP).
PARP inhibitori blokiraju enzim koji se zove poli(adenozin difosfat riboza) polimeraza (PARP).
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.
The recommended starting dose is 3 capsules taken together once a day (total daily dose of 300 mg), with or without food.
Preporučena početna doza je 3 kapsule uzete jedna za drugom, jednom na dan (ukupna doza od 300 mg), s hranom ili bez nje.
If adverse reactions are not manageable with this strategy of dose interruption and reduction, it is recommended that Zejula be discontinued.
Ako se nuspojave ne mogu zbrinuti ovom strategijom prekidanja uzimanja i smanjenja doze, preporučuje se ukidanje lijeka Zejula.
Within each cohort, patients were randomised using a 2:1 allocation of niraparib and placebo.
U svakoj skupini bolesnici su randomizirani u odnosu 2:1 kako bi im se dodijelio niraparib i placebo.
Following a signal regarding sepsis with niraparib, a number of relevant cases were identified.
Praćenjem signala sepse koja se javljala uz niraparib, uočen je određen broj relevantnih slučajeva.
Your doctor will test your blood regularly throughout your treatment.
Vaš će Vam liječnik redovito provjeravati krvnu sliku tijekom liječenja.
The most common serious adverse reactions > 1 % (treatment-emergent frequencies) were thrombocytopenia and anaemia.
Najčešće ozbiljne nuspojave > 1 % (učestalosti zabilježene tijekom liječenja) bile su trombocitopenija i anemija.
• Swelling in the feet, ankles, legs, and/or hands
• oticanje stopala, gležnjeva, nogu i/ili šaka
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.
U zbirnim uzorcima, prikupljanima tijekom 6 dana, u urinu je pronađeno 40,0 % doze i to primarno u obliku metabolita, a 31,6 % doze pronađeno je u fecesu, primarno kao nepromijenjeni niraparib.
Uncommon (may affect up to 1 in 100 people) • Reduction in the number of red blood cells, white blood cells and platelets
Manje često (mogu se javiti u do 1 na 100 osoba) • smanjenje broja crvenih krvnih stanica, bijelih krvnih stanica i trombocita
84 × 1 hard capsules 56 × 1 hard capsules 28 × 1 hard capsules
84 × 1 tvrda kapsula 56 × 1 tvrda kapsula 28 × 1 tvrda kapsula
If MDS and/or AML are confirmed while on treatment with Zejula, treatment should be discontinued and the patient treated appropriately.
Ako se tijekom liječenja lijekom Zejula potvrdi MDS i/ili AML, liječenje treba prekinuti te bolesnika odgovarajuće liječiti.
Increased plasma concentrations of co-administered medicinal products that are substrates of these transporters (e.g. metformin) cannot be excluded.
Povećane koncentracije istodobno primijenjenih lijekova koji su supstrati tih prijenosnika (npr. metformina) u plazmi ne mogu se isključiti.
Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased
Povišena gama-glutamil transferaza, povišen AST, povišen kreatinin u krvi, povišen ALT, povišena alkalna fosfataza u krvi, smanjena tjelesna težina
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 tBRCA mutaciju i deficijenciju homologne rekombinacije (HRD) provedeno je pomoću testa HRD na tumorskom tkivu uzetom u vrijeme početne dijagnoze ili u vrijeme povratka bolesti.
Bronchitis, conjunctivitis
Bronhitis, konjunktivitis
On the basis of the scientific conclusions for niraparib, the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing niraparib is unchanged subject to the proposed changes to the product information.
Na temelju znanstvenih zaključaka za niraparib, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) niraparib nepromijenjen, uz predložene izmjene informacija o lijeku.
Therefore, the PRAC concluded that “febrile neutropenia” should be added as a new adverse drug reaction in section 4.8 of the SmPC with the frequency “uncommon.” The package leaflet should be updated accordingly.
Stoga je PRAC zaključio da se „febrilna neutropenija“ treba dodati kao nova nuspojava lijeka u dio 4.8 sažetka opisa svojstava lijeka s učestalošću „manje često“.
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.
Inhibicija CYP enzima (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP3A4) Ni niraparib ni M1 nisu inhibitori nijednog CYP enzima za metabolizam aktivnih tvari, odnosno CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ni CYP3A4/5.
Tell your doctor straight away if you notice any of the following SERIOUS side effects - you may need urgent medical treatment:
Ako primijetite bilo koju od sljedećih OZBILJNIH nuspojava, odmah se obratite liječniku jer je moguće da trebate hitno liječenje:
It is unknown whether niraparib or its metabolites are excreted in human milk.
Nije poznato izlučuju li se niraparib ili njegovi metaboliti u majčino mlijeko.
High blood pressure
Visok krvni tlak
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.
Ako je potrebno daljnje smanjenje doze, može se primijeniti drugo smanjenje doze s dvije tvrde kapsule dnevno (200 mg) na jednu tvrdu kapsulu dnevno (100 mg).
The incidence of Grade 3 or 4 ADRs was greater among low body weight patients (78 %) than high body weight patients (53 %).
Učestalost nuspojava 3. ili 4. stupnja bila je veća u bolesnika s malom tjelesnom težinom (78 %) nego u onih s velikom tjelesnom težinom (53 %).
Haematologic adverse reaction requiring transfusion or haematopoietic growth factor support
Hematološka nuspojava koja zahtijeva primjenu transfuzije ili hematopoetskog faktora rasta
Frequency of all CTCAE grades
Učestalost svih stupnjeva prema CTCAE
In the clinical programme, blood pressure measurements were obtained on Day 1 of each 28-day cycle while the patient remained on Zejula.
U kliničkom programu mjerenja krvnog tlaka obavljana su prvog dana svakog dvadesetosmodnevnog ciklusa sve dok su bolesnici liječeni Zejulom.
Frequency of CTCAE grade 3 or 4
Učestalost 3. ili 4. stupnja prema CTCAE
P value gBRCAmut non-gBRCAmut
p-vrijednost gBRCAmut non-gBRCAmut
AST increased, ALT increased, blood alkaline phosphatase increased
Povišen AST, povišen ALT, povišena alkalna fosfataza u krvi
Zejula hard capsules contain lactose monohydrate.
Zejula tvrde kapsule sadrže laktozu hidrat.
Swallow the capsules whole, with some water.
Kapsule progutajte cijele s nešto vode.
Effect of niraparib on other medicinal products
Utjecaj nirapariba na druge lijekove
• The active substance is niraparib.
• Djelatna tvar je niraparib.
If you are a woman who could become pregnant you must use reliable contraception while you are taking Zejula, and you must continue to use reliable contraception for 1 month after taking your last dose.
Ako ste žena koja može zatrudnjeti, morate koristiti pouzdanu kontracepciju dok uzimate lijek Zejula i morate nastaviti koristiti pouzdanu kontracepciju još mjesec dana nakon što ste uzeli zadnju dozu.
Eligible patients were assigned to one of two cohorts based on the results of a germline BRCA mutation test.
Pogodni bolesnici dodijeljeni su u jednu od dvije skupine na temelju rezultata testiranja BRCA mutacija zametnih stanica.
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.
Primarna analiza djelotvornosti za PFS bila je određena slijepom središnjom nezavisnom procjenom (engl. independent review committee, IRC) i bila je prospektivno definirana i procijenjena posebno za skupinu gBRCAmut i skupinu non-gBRCAmut.
Paediatric population No studies have been conducted in paediatric patients.
Pedijatrijska populacija Nisu provedena ispitivanja u pedijatrijskih bolesnika.
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.
Hematološke nuspojave (trombocitopenija, anemija, neutropenija), uključujući kliničke dijagnoze i/ili laboratorijske nalaze, općenito su se javljale rano tijekom liječenja niraparibom, a učestalost se s vremenom smanjivala.
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).
Sekundarne mjere ishoda CFI, TFST i PFS2 pokazale su statistički značajan i trajan učinak liječenja u korist grane liječene niraparibom u skupini gBRCAmut i cijeloj non-gBRCAmut (Tablica 5).
Platelet count < 100,000/μL
Broj trombocita < 100 000/μl
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.
Prije otkrivanja slijepe šifre ispitivanja tumori bolesnika bili su testirani na prisutnost HRD-a pomoću eksperimentalnog testa za HRD kojim se procjenjuju tri indirektne mjere nestabilnosti tumorskog genoma: gubitak heterozigotnosti, nejednakost alela telomera i velike promjene stanja kromatida (lomovi kromatida, engl. large-scale state transitions).
The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg.
Doza je tri tvrde kapsule od 100 mg jednom dnevno, što odgovara ukupnoj dnevnoj dozi od 300 mg.
• 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).
• Otežano disanje, jak umor, blijeda koža ili ubrzani otkucaji srca - to mogu biti znakovi niskog broja crvenih krvnih stanica (anemije).
When you are taking Zejula it may make you feel weak, tired or dizzy and therefore influence your ability to drive and use machines.
Uzimanje lijeka Zejula može uzrokovati slabost, umor ili omaglicu i zato može utjecati na Vašu sposobnost da upravljate vozilima i strojevima.
Anxiety, depression
Anksioznost, depresija
Do not chew or crush the capsules.
Kapsule nemojte žvakati ili drobiti.
Patients treated with Zejula who develop thrombocytopenia might have an increased risk of haemorrhage.
Bolesnici liječeni lijekom Zejula koji razviju trombocitopeniju mogu imati povećan rizik od krvarenja.
Gamma-glutamyl transferase increased * Frequencies are based on percent of patients using all-causality adverse events.
Povišena gama-glutamil transferaza * Učestalosti se temelje na postotku bolesnika uzimajući u obzir štetne događaje bilo kojeg uzroka.
Median (95 % CI) - mo
medijan (95 % CI) - mo
Hard capsule
Tvrde kapsule
A reversible reduction of spermatogenesis was observed in rats and dogs (see section 5.3).
U štakora i pasa uočena je reverzibilna redukcija spermatogeneze (vidjeti dio 5.3).
Niraparib is an inhibitor of MATE1 and -2 with IC50 of 0.18 µM and ≤ 0.14 µM, respectively.
Niraparib je inhibitor MATE1 i 2 s IC50 od 0,18 µM odnosno ≤ 0,14 µM.
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 udio bolesnika u obje terapijske grane i u obje skupine prethodno je primio 3 ili više linija kemoterapije, uključujući 49 % bolesnika u skupini gBRCAmut i 34 % bolesnika u skupini non-gBRCAmut koji su primali niraparib.
The data on niraparib in combination with cytotoxic medicinal products are limited.
Podaci o primjeni nirapariba u kombinaciji s citotoksičnim lijekovima su ograničeni.
In vitro, niraparib weakly induces CYP1A2 at high concentrations and the clinical relevance of this effect would not be completely ruled out.
In vitro, niraparib slabo inducira CYP1A2 pri visokim koncentracijama te se klinički značaj ovog učinka ne može potpuno isključiti.
The combination of niraparib with vaccines or immunosuppressant agents has not been studied.
Kombinacija nirapariba s cjepivima ili imunosupresivnim lijekovima nije ispitana.
Zejula hard capsules have a white opaque body and a purple opaque cap.
Zejula tvrde kapsule imaju neprozirno bijelo tijelo i neprozirnu ljubičastu kapicu.
The cases were typical of secondary, cancer therapy-related MDS/AML.
Slučajevi su bili karakteristični za sekundarne MDS/AML povezane s liječenjem maligniteta.
Following multiple oral doses of niraparib from 30 mg to 400 mg once daily, accumulation of niraparib was approximately 2 to 3 folds.
Nakon višekratnih oralnih doza nirapariba od 30 do 400 mg jednom dnevno, akumulacija nirapariba bila je otprilike dvostruka do trostruka.
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.
Ako dojite, morate prestati prije početka uzimanja lijeka Zejula i ne smijete ponovo početi dojiti dok ne prođe 1 mjesec od uzimanja posljednje doze.
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.
U analizi populacijske farmakokinetike prema podacima iz kliničkih ispitivanja na bolesnicima, prethodno postojeće blago (CLCr < 90 - ≥ 60 ml/min) i umjereno (CLCr < 60 - ≥ 30 mL/min) oštećenje funkcije bubrega nije utjecalo na klirens nirapariba.
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Italia TESARO Bio Italy S.r.l.
A starting dose of 200 mg for patients weighing less than 58 kg may be considered.
U bolesnika s tjelesnom težinom manjom od 58 kg može se razmotriti početna doza od 200 mg.
Urinary tract infection, bronchitis
Infekcija mokraćnog sustava, bronhitis
Thrombocytopenia occurred more commonly in patients whose baseline platelet count was less than 180 × 109/L.
Trombocitopenija se češće javljala u bolesnika čiji je početni broj trombocita bio manji od 180 × 109/l.
Hazard ratio (95 % CI) *CI denotes confidence interval, gBRCAmut germline BRCA mutation, and NR not reached
omjer hazarda (95 % CI) *CI označava interval pouzdanosti, gBRCAmut mutaciju BRCA u zametnim stanicama, a NR nije dosegnuto
PFS median (95% CI*)
medijan PFS-a (95 % CI*)
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).
U svakoj skupini randomizacija je bila stratificirana prema vremenu do progresije bolesti nakon predzadnje terapije koja je sadržavala platinu prije uključivanja u ispitivanje (6 do < 12 mjeseci i ≥ 12 mjeseci); prema tome jesu li ili nisu primali bevacizumab zajedno s predzadnjim ili zadnjim režimom s platinom te prema najboljem odgovoru na posljednji režim s platinom (potpuni ili djelomični odgovor).
• Decrease in weight
• smanjenje tjelesne težine
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 %)].
Nakon primjene jednokratne doze od 300 mg nirapariba natašte, niraparib je bio mjerljiv u plazmi unutar 30 minuta, a srednja vrijednost vršne koncentracije u plazmi (Cmax) nirapariba dosegnuta je za otprilike 3 sata [804 ng/ml (% CV:50,2 %)].
• For patients with platelet count ≤ 10,000/μL, platelet transfusion should be considered.
U bolesnika s brojem trombocita ≥ 10 000/μl, treba razmotriti davanje transfuzije trombocita.
What you need to know before you take Zejula Do not take Zejula
Što morate znati prije nego počnete uzimati lijek Zejula
(Nir:plac) (95 % CI*) * CI denotes confidence interval.
p-vrijednost omjer hazarda (HR) (nir : plac) (95 % CI*) * CI označava interval pouzdanosti.
In mice, single doses of niraparib increased intracellular levels of dopamine and metabolites in cortex.
U miševa su jednokratne doze nirapariba povećale unutarstanične razine dopamina i metabolita u korteksu.
Breast-feeding is contraindicated during administration of Zejula and for 1 month after receiving the last dose (see section 4.3).
Dojenje je kontraindicirano tijekom primjene lijeka Zejula i još 1 mjesec nakon primanja posljednje doze (vidjeti dio 4.3).
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Sverige TESARO Bio Sweden AB
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 nije bio mutagen u testu reverzije mutacije u bakterija (Amesov test), ali je bio klastogen u in vitro testu kromosomskih aberacija u sisavaca i u in vivo mikronukleus testu koštane srži štakora.
In a population pharmacokinetic analysis of niraparib, the Vd/F was 1,074 L in cancer patients, indicating extensive tissue distribution of niraparib.
U analizi populacijske farmakokinetike nirapariba, Vd/F je iznosio 1074 l u bolesnika s rakom, što upućuje na opsežnu tkivnu distribuciju nirapariba.
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).
Zejula se ne smije primjenjivati tijekom trudnoće ili u žena reproduktivne dobi koje ne žele koristiti učinkovitu kontracepciju tijekom liječenja i još 1 mjesec nakon posljednje doze lijeka Zejula (vidjeti dio 4.6).