FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: Bronchitis, conjunctivitis
Croatian: Bronhitis, konjunktivitis
English: 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.
Croatian: 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.
English: 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.
Croatian: 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“.
English: 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.
Croatian: 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.
English: Tell your doctor straight away if you notice any of the following SERIOUS side effects - you may need urgent medical treatment:
Croatian: Ako primijetite bilo koju od sljedećih OZBILJNIH nuspojava, odmah se obratite liječniku jer je moguće da trebate hitno liječenje:
English: It is unknown whether niraparib or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se niraparib ili njegovi metaboliti u majčino mlijeko.
English: High blood pressure
Croatian: Visok krvni tlak
English: 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.
Croatian: 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).
English: The incidence of Grade 3 or 4 ADRs was greater among low body weight patients (78 %) than high body weight patients (53 %).
Croatian: Učestalost nuspojava 3. ili 4. stupnja bila je veća u bolesnika s malom tjelesnom težinom (78 %) nego u onih s velikom tjelesnom težinom (53 %).
English: Haematologic adverse reaction requiring transfusion or haematopoietic growth factor support
Croatian: Hematološka nuspojava koja zahtijeva primjenu transfuzije ili hematopoetskog faktora rasta
English: Frequency of all CTCAE grades
Croatian: Učestalost svih stupnjeva prema CTCAE
English: In the clinical programme, blood pressure measurements were obtained on Day 1 of each 28-day cycle while the patient remained on Zejula.
Croatian: U kliničkom programu mjerenja krvnog tlaka obavljana su prvog dana svakog dvadesetosmodnevnog ciklusa sve dok su bolesnici liječeni Zejulom.
English: Frequency of CTCAE grade 3 or 4
Croatian: Učestalost 3. ili 4. stupnja prema CTCAE
English: P value gBRCAmut non-gBRCAmut
Croatian: p-vrijednost gBRCAmut non-gBRCAmut
English: AST increased, ALT increased, blood alkaline phosphatase increased
Croatian: Povišen AST, povišen ALT, povišena alkalna fosfataza u krvi
English: Zejula hard capsules contain lactose monohydrate.
Croatian: Zejula tvrde kapsule sadrže laktozu hidrat.
English: Swallow the capsules whole, with some water.
Croatian: Kapsule progutajte cijele s nešto vode.
English: Effect of niraparib on other medicinal products
Croatian: Utjecaj nirapariba na druge lijekove
English: • The active substance is niraparib.
Croatian: • Djelatna tvar je niraparib.
English: 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.
Croatian: 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.
English: Eligible patients were assigned to one of two cohorts based on the results of a germline BRCA mutation test.
Croatian: Pogodni bolesnici dodijeljeni su u jednu od dvije skupine na temelju rezultata testiranja BRCA mutacija zametnih stanica.
English: 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.
Croatian: 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.
English: Paediatric population No studies have been conducted in paediatric patients.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja u pedijatrijskih bolesnika.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Platelet count < 100,000/μL
Croatian: Broj trombocita < 100 000/μl
English: 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.
Croatian: 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).
English: The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg.
Croatian: Doza je tri tvrde kapsule od 100 mg jednom dnevno, što odgovara ukupnoj dnevnoj dozi od 300 mg.
English: • 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).
Croatian: • Otežano disanje, jak umor, blijeda koža ili ubrzani otkucaji srca - to mogu biti znakovi niskog broja crvenih krvnih stanica (anemije).
English: When you are taking Zejula it may make you feel weak, tired or dizzy and therefore influence your ability to drive and use machines.
Croatian: Uzimanje lijeka Zejula može uzrokovati slabost, umor ili omaglicu i zato može utjecati na Vašu sposobnost da upravljate vozilima i strojevima.
English: Anxiety, depression
Croatian: Anksioznost, depresija
English: Do not chew or crush the capsules.
Croatian: Kapsule nemojte žvakati ili drobiti.
English: Patients treated with Zejula who develop thrombocytopenia might have an increased risk of haemorrhage.
Croatian: Bolesnici liječeni lijekom Zejula koji razviju trombocitopeniju mogu imati povećan rizik od krvarenja.
English: Gamma-glutamyl transferase increased * Frequencies are based on percent of patients using all-causality adverse events.
Croatian: Povišena gama-glutamil transferaza * Učestalosti se temelje na postotku bolesnika uzimajući u obzir štetne događaje bilo kojeg uzroka.
English: Median (95 % CI) - mo
Croatian: medijan (95 % CI) - mo
English: Hard capsule
Croatian: Tvrde kapsule
English: A reversible reduction of spermatogenesis was observed in rats and dogs (see section 5.3).
Croatian: U štakora i pasa uočena je reverzibilna redukcija spermatogeneze (vidjeti dio 5.3).
English: Niraparib is an inhibitor of MATE1 and -2 with IC50 of 0.18 µM and ≤ 0.14 µM, respectively.
Croatian: Niraparib je inhibitor MATE1 i 2 s IC50 od 0,18 µM odnosno ≤ 0,14 µM.
English: 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.
Croatian: 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.
English: The data on niraparib in combination with cytotoxic medicinal products are limited.
Croatian: Podaci o primjeni nirapariba u kombinaciji s citotoksičnim lijekovima su ograničeni.
English: In vitro, niraparib weakly induces CYP1A2 at high concentrations and the clinical relevance of this effect would not be completely ruled out.
Croatian: In vitro, niraparib slabo inducira CYP1A2 pri visokim koncentracijama te se klinički značaj ovog učinka ne može potpuno isključiti.
English: The combination of niraparib with vaccines or immunosuppressant agents has not been studied.
Croatian: Kombinacija nirapariba s cjepivima ili imunosupresivnim lijekovima nije ispitana.
English: Zejula hard capsules have a white opaque body and a purple opaque cap.
Croatian: Zejula tvrde kapsule imaju neprozirno bijelo tijelo i neprozirnu ljubičastu kapicu.
English: The cases were typical of secondary, cancer therapy-related MDS/AML.
Croatian: Slučajevi su bili karakteristični za sekundarne MDS/AML povezane s liječenjem maligniteta.
English: Following multiple oral doses of niraparib from 30 mg to 400 mg once daily, accumulation of niraparib was approximately 2 to 3 folds.
Croatian: Nakon višekratnih oralnih doza nirapariba od 30 do 400 mg jednom dnevno, akumulacija nirapariba bila je otprilike dvostruka do trostruka.
English: 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.
Croatian: Ako dojite, morate prestati prije početka uzimanja lijeka Zejula i ne smijete ponovo početi dojiti dok ne prođe 1 mjesec od uzimanja posljednje doze.
English: 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.
Croatian: 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.
English: TESARO Bio Italy S.r.l.
Croatian: Italia TESARO Bio Italy S.r.l.
English: A starting dose of 200 mg for patients weighing less than 58 kg may be considered.
Croatian: U bolesnika s tjelesnom težinom manjom od 58 kg može se razmotriti početna doza od 200 mg.
English: Urinary tract infection, bronchitis
Croatian: Infekcija mokraćnog sustava, bronhitis
English: Thrombocytopenia occurred more commonly in patients whose baseline platelet count was less than 180 × 109/L.
Croatian: Trombocitopenija se češće javljala u bolesnika čiji je početni broj trombocita bio manji od 180 × 109/l.
English: Hazard ratio (95 % CI) *CI denotes confidence interval, gBRCAmut germline BRCA mutation, and NR not reached
Croatian: omjer hazarda (95 % CI) *CI označava interval pouzdanosti, gBRCAmut mutaciju BRCA u zametnim stanicama, a NR nije dosegnuto
English: PFS median (95% CI*)
Croatian: medijan PFS-a (95 % CI*)
English: 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).
Croatian: 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).
English: • Decrease in weight
Croatian: • smanjenje tjelesne težine
English: 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 %)].
Croatian: 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 %)].
English: • For patients with platelet count ≤ 10,000/μL, platelet transfusion should be considered.
Croatian: U bolesnika s brojem trombocita ≥ 10 000/μl, treba razmotriti davanje transfuzije trombocita.
English: What you need to know before you take Zejula Do not take Zejula
Croatian: Što morate znati prije nego počnete uzimati lijek Zejula
English: (Nir:plac) (95 % CI*) * CI denotes confidence interval.
Croatian: p-vrijednost omjer hazarda (HR) (nir : plac) (95 % CI*) * CI označava interval pouzdanosti.
English: In mice, single doses of niraparib increased intracellular levels of dopamine and metabolites in cortex.
Croatian: U miševa su jednokratne doze nirapariba povećale unutarstanične razine dopamina i metabolita u korteksu.
English: Breast-feeding is contraindicated during administration of Zejula and for 1 month after receiving the last dose (see section 4.3).
Croatian: Dojenje je kontraindicirano tijekom primjene lijeka Zejula i još 1 mjesec nakon primanja posljednje doze (vidjeti dio 4.3).
English: TESARO Bio Sweden AB
Croatian: Sverige TESARO Bio Sweden AB
English: 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.
Croatian: 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.
English: In a population pharmacokinetic analysis of niraparib, the Vd/F was 1,074 L in cancer patients, indicating extensive tissue distribution of niraparib.
Croatian: U analizi populacijske farmakokinetike nirapariba, Vd/F je iznosio 1074 l u bolesnika s rakom, što upućuje na opsežnu tkivnu distribuciju nirapariba.
English: 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).
Croatian: 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).
English: Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair.
Croatian: Niraparib je inhibitor enzima poli(ADP-riboza) polimeraza (PARP), PARP1 i PARP2, koje imaju ulogu u popravku DNK.
English: Treatment A: Niraparib
Croatian: niraparib
English: A concomitant high-fat meal did not significantly affect the pharmacokinetics of niraparib after administration of 300 mg of niraparib.
Croatian: Istodobni obrok s visokim udjelom masnoća nije značajno utjecao na farmakokinetiku nirapariba nakon primjene 300 mg nirapariba.
English: Niraparib is not a substrate of MATE 1 or 2, while M1 is a substrate of both.
Croatian: Niraparib nije supstrat MATE1 ni 2, dok je M1 supstrat oba prijenosnika.
English: The safety and efficacy of niraparib as maintenance therapy was studied in a Phase 3 randomised, double-blind, placebo-controlled international trial (ENGOT-OV16 / NOVA) in patients with relapsed predominantly high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by complete response (CR) or partial response (PR) for more than six months to their penultimate (next to last) platinum-based therapy.
Croatian: Sigurnost i djelotvornost nirapariba kao terapije održavanja ispitivane su u randomiziranom, dvostruko slijepom, placebom kontroliranom, međunarodnom ispitivanju faze 3 (ENGOT-OV16/NOVA) u bolesnika s predominantno seroznim karcinomom jajnika, jajovoda ili primarno peritoneuma visokog stupnja u relapsu, koji su bili osjetljivi na platinu, definirano kao potpuni odgovor (engl. complete response, CR) ili djelomični odgovor (engl. partial response, PR) tijekom više od 6 mjeseci na predzadnju terapiju koja je sadržavala platinu.
English: In vitro, niraparib inhibited the dopamine transporter DAT at concentration levels below human exposure levels.
Croatian: Niraparib je in vitro inhibirao prijenosnik dopamina DAT pri koncentracijama nižima od razina izloženosti u ljudi.
English: First occurrence:
Croatian: Prvi nastup:
English: A sensitivity analysis of investigator PFS showed the following results for the gBRCAmut cohort: HR 0.27 (95 % CI*, 0.182, 0.401; p < 0.0001); median PFS 14.8 months (95% CI*, 12.0, 16.6) for niraparib and median PFS 5.5 months (95% CI*, 4.9, 7.2) for placebo, and for the non-gBRCAmut cohort: HR 0.53 (95 % CI*, 0.405, 0.683; p < 0.0001); median PFS 8.7 months (95 % CI*, 7.3, 10.0) for niraparib and median PFS 4.3 months (95% CI*, 3.7, 5.5) for placebo.
Croatian: Analiza osjetljivosti PFS-a istraživača pokazala je sljedeće rezultate za skupinu gBRCAmut: HR 0,27 (95 % CI* 0,182; 0,401; p < 0,0001); medijan PFS-a 14,8 mjeseci (95 % CI* 12,0; 16,6) za niraparib i medijan PFS-a 5,5 mjeseci (95 % CI* 4,9; 7,2) za placebo; a za skupinu non-gBRCAmut: HR 0,53 (95 % CI* 0,405; 0,683; p < 0,0001); medijan PFS-a 8,7 mjeseci (95 % CI* 7,3; 10,0) za niraparib i medijan PFS-a 4,3 mjeseca (95 % CI* 3,7; 5,5) za placebo.
English: Neither niraparib nor M1 is a CYP3A4 inducer in vitro.
Croatian: Ni niraparib ni M1 nisu induktori CYP3A4 in vitro.
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of niraparib in paediatric patients.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja kako bi se istražila farmakokinetika nirapariba u pedijatrijskih bolesnika.
English: 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).
Croatian: Podaci o ishodu koje su prijavili bolesnici na temelju validiranih istraživačkih alata (FOSI i EQ-5D) pokazuju da nije bilo razlike između bolesnika liječenih niraparibom i bolesnika koji su primali placebo u mjerama povezanima s kvalitetom života.
English: In most cases, hypertension was controlled adequately using standard antihypertensive treatment with or without Zejula dose adjustment (see section 4.2).
Croatian: U većini je slučajeva hipertenzija odgovarajuće kontrolirana primjenom standardnog antihipertenzivnog liječenja uz prilagodbu ili bez prilagodbe doze lijeka Zejula (vidjeti dio 4.2).
English: Discontinuation due to hypertension occurred in < 1 % of patients.
Croatian: Do prekida zbog hipertenzije došlo je u < 1 % bolesnika.
English: 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.
Croatian: Nakon peroralne primjene jednokratne doze od 300 mg [14C]-nirapariba, prosječno je 86,2 % (raspon 71 % do 91 %) doze pronađeno u urinu i fecesu tijekom 21 dana.
English: Figure 1: Kaplan-Meier plot for progression-free survival in the gBRCAmut cohort based on IRC assessment (ITT population, N = 203)
Croatian: Slika 1: Kaplan-Meierov grafikon preživljenja bez progresije bolesti u skupini gBRCAmut na temelju procjene IRC-a (ITT populacija, N = 203)
English: 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).
Croatian: Zejula se koristi u odraslih žena za liječenje raka jajnika, jajovoda (dio ženskog spolnog sustava koji povezuje jajnike s maternicom) ili peritoneuma (opna koja obavija organe u trbušnoj šupljini).
English: • High blood pressure
Croatian: • visok krvni tlak
English: Carcinogenicity studies have not been conducted with niraparib.
Croatian: Ispitivanja kancerogenosti za niraparib nisu provedena.
English: Niraparib can cause haematological toxicity that includes febrile neutropenia.
Croatian: Niraparib može imati toksične učinke na hematološki sustav, što uključuje pojavu febrilne neutropenije.
English: 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.
Croatian: Tvrda kapsula veličine približno 22 mm × 8 mm, bijelog tijela na kojem je crnom bojom otisnuto „100 mg“ i ljubičaste kapice na kojoj je bijelom bojom otisnuto „Niraparib“.
English: Reproductive and developmental toxicity studies have not been conducted with niraparib.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti za niraparib nisu provedena.
English: In vitro, niraparib weakly inhibits the organic cation transporter 1 (OCT1) with an IC50 = 34.4 µM.
Croatian: In vitro, niraparib slabo inhibira prijenosnik organskih kationa 1 (OCT1) s IC50 = 34,4 µM.
English: Discontinuation due to thrombocytopenia events (thrombocytopenia and platelet count decreased) occurred in approximately 3 % of the patients.
Croatian: Do prekida zbog slučajeva trombocitopenije (trombocitopenije i smanjenja broja trombocita) došlo je u približno 3 % bolesnika.
English: Zejula contains the active substance niraparib.
Croatian: Zejula sadrži djelatnu tvar niraparib.
English: • Resume Zejula at same or reduced dose based on clinical evaluation.
Croatian: Nastavite primjenu lijeka Zejula s istom ili smanjenom dozom ovisno o kliničkoj procjeni.
English: In the NOVA study, 48 % of patients had a dose interruption in Cycle 1.
Croatian: U ispitivanju NOVA u 48 % bolesnika došlo je do prekida liječenja u 1. ciklusu.
English: A possible cause for sepsis is a low neutrophil count and there is a potential association between niraparib and developing sepsis.
Croatian: Nizak broj neutrofila može uzrokovati sepsu i to je moguća poveznica između nirapariba i razvoja sepse.