FrancophonIA/ELRC3.0 huggingface dataset:
English: The study met its primary objective of statistically significantly improved PFS for niraparib maintenance monotherapy compared with placebo in the gBRCAmut cohort (HR 0.27; 95 % CI* 0.173, 0.410; p < 0.0001) as well as in the overall non-gBRCAmut cohort (HR 0.45; 95 % CI* 0.338, 0.607; p < 0.0001).
Croatian: Ispitivanje je ostvarilo primarni cilj statistički značajnog poboljšanja PFS-a pri terapiji održavanja niraparibom u monoterapiji u usporedbi s placebom u gBRCAmut skupini (HR 0,27; 95 % CI* 0,173; 0,410; p < 0,0001) kao i u cijeloj non-gBRCAmut skupini (HR 0,45; 95 % CI* 0,338; 0,607; p < 0,0001).
English: Figure 2: Kaplan-Meier plot for progression-free survival in the non-gBRCAmut cohort overall based on IRC assessment (ITT population, N = 350)
Croatian: Slika 2: Kaplan-Meierov grafikon preživljenja bez progresije bolesti u cijeloj skupini non-gBRCAmut na temelju procjene IRC-a (ITT populacija, N = 350)
English: • 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).
Croatian: • Drugi sastojci (pomoćne tvari) su: sadržaj kapsule: magnezijev stearat, laktoza hidrat ovojnica kapsule: titanijev dioksid (E 171), želatina, brilliant blue FCF (E 133), eritrozin (E 127), tartrazin (E 102) tinta za označavanje: šelak (E 904), propilenglikol (E 1520), kalijev hidroksid (E 525), crni željezov oksid (E 172), natrijev hidroksid (E 524) i povidon (E 1201).
English: Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Zejula dose (see section 4.2), if necessary.
Croatian: Hipertenziju treba zbrinuti antihipertenzivnim lijekovima kao i prilagodbom doze lijeka Zejula (vidjeti dio 4.2) ako je potrebno.
English: Dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis
Croatian: Suhoća usta, abdominalna distenzija, upala sluznica (uključujući mukozitis), stomatitis
English: Progression-free survival was determined per RECIST (Response Evaluation Criteria in Solid Tumors, version 1.1) or clinical signs and symptoms and increased CA-125.
Croatian: Response Evaluation Criteria in Solid Tumors, RECIST) ili kliničkim znakovima i simptomima te povišenim CA125.
English: Caution is recommended when niraparib is combined with active substances that undergo an uptake transport by OCT1 such as metformin.
Croatian: Preporučuje se oprez kad se niraparib kombinira s djelatnim tvarima koje se unose putem prijenosnika OCT1, kao što je metformin.
English: 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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Zejula u svim podskupinama pedijatrijske populacije za karcinom jajnika (isključujući rabdomiosarkom i tumore zametnih stanica).
English: Second occurrence:
Croatian: Drugi nastup:
English: • Feelings of sadness, depressed
Croatian: • osjećaj tuge, depresiju
English: Shellac (E 904) Propylene glycol (E 1520) Potassium hydroxide (E 525) Black iron oxide (E 172) Sodium hydroxide (E 524) Povidone (E 1201)
Croatian: Tinta za označavanje šelak (E 904) propilenglikol (E 1520) kalijev hidroksid (E 525) crni željezov oksid (E 172) natrijev hidroksid (E 524) povidon (E 1201)
English: 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.
Croatian: Povećana citotoksičnost nirapariba uočena je u staničnim linijama tumora sa ili bez deficijencije tumor supresorskih gena BRCA 1 i 2 (engl.
English: Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the niraparib and placebo arms in the gBRCAmut (n = 203) and the non-gBRCAmut cohorts (n = 350).
Croatian: Demografske karakteristike, početne karakteristike bolesti i povijest prethodnog liječenja bile su općenito ujednačene u skupinama gBRCAmut (n = 203) i non-gBRCAmut (n = 350) za niraparib i placebo granu.
English: If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued.
Croatian: Ako se u bolesnika razvije teška perzistentna hematološka toksičnost, uključujući pancitopeniju, koja se ne povuče unutar 28 dana od prekida, liječenje lijekom Zejula treba se prekinuti.
English: Niraparib as a substrate of CYPs (CYP1A2 and CYP3A4) Niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs) in vivo.
Croatian: Niraparib kao supstrat CYP enzima (CYP1A2 i CYP3A4) Niraparib je supstrat karboksilesteraza i UDP-glukuronoziltransferaza in vivo.
English: Table 4: Summary of primary objective outcomes in the ENGOT-OV16 study gBRCAmut cohort
Croatian: Tablica 4: Sažetak ishoda primarnog cilja u ispitivanju ENGOT-OV16 skupina gBRCAmut skupina non-gBRCAmut niraparib
English: In the HRDneg group, the hazard ratio was 0.58 (95 % CI, 0.361, 0.922; p = 0.0226).
Croatian: U skupini HRDneg omjer hazarda bio je 0,58 (CI 95 % 0,361; 0,922; p = 0,0226).
English: Women of childbearing potential must use effective contraception during therapy and for 1 month after receiving the last dose of Zejula.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i još mjesec dana nakon primanja posljednje doze lijeka Zejula.
English: Hazard ratio (95 % CI) Progression-free survival 2
Croatian: p-vrijednost omjer hazarda (95 % CI) preživljenje bez progresije bolesti 2
English: Caution is then recommended when niraparib is combined with substrates of BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin, and methotrexate).
Croatian: Zato se preporučuje oprez kad se niraparib kombinira sa supstratima BCRP-a (irinotekanom, rosuvastatinom, simvastatinom, atorvastatinom i metotreksatom).
English: *CTCAE=Common Terminology Criteria for Adverse Events
Croatian: Common Terminology Criteria for
English: Oxidative metabolism of niraparib is minimal in vivo.
Croatian: Oksidativni metabolizam nirapariba in vivo je minimalan.
English: 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.
Croatian: Na neprozirnom bijelom tijelu kapsule je crnom bojom otisnuto „100 mg“, a na ljubičastoj kapici kapsule je bijelom bojom otisnuto „Niraparib“.
English: Discontinuation due to anaemia occurred in 1 % of patients.
Croatian: Do prekida zbog anemije došlo je u 1 % bolesnika.
English: Therefore, caution should be taken if niraparib is used in combination with vaccines, immunosuppressant agents or with other cytotoxic medicinal products.
Croatian: Zbog toga je potreban oprez u slučaju primjene nirapariba u kombinaciji s cjepivima, imunosupresivnim lijekovima ili drugim citotoksičnim lijekovima.
English: Myelodysplastic syndrome/acute myeloid leukaemia
Croatian: Mijelodisplastični sindrom / akutna mijeloična leukemija
English: Blood pressure should be monitored monthly for the first year and periodically thereafter during treatment with Zejula.
Croatian: Krvni tlak treba kontrolirati jednom mjesečno u prvoj godini liječenja lijekom Zejula te povremeno nakon toga.
English: Niraparib is not a substrate of bile salt export pump (BSEP).
Croatian: Niraparib nije supstrat pumpe za izbacivanje žučnih soli (BSEP-a).
English: Some of the patients had a history of bone marrow dysplasia.
Croatian: Neki od bolesnika imali su u anamnezi displaziju koštane srži.
English: 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.
Croatian: Kod seroznog karcinoma jajnika visokog stupnja koji je uzgajan u miševima kao ortotopično smješten ksenograft tumora uzet iz bolesnika (engl. patient-derived xenograft, PDX), pokazalo se da niraparib smanjuje rast tumora s mutacijom BRCA 1 i 2; u tumora divljeg tipa s obzirom na BRCA, ali s deficijencijom homologne rekombinacije te u tumora koji su divljeg tipa s obzirom na BRCA i bez uočljive deficijencije homologne rekombinacije.
English: Discontinuation due to neutropenia events occurred in 2 % of patients.
Croatian: Do prekida zbog slučajeva neutropenije došlo je u 2 % bolesnika.
English: Also contains lactose and tartrazine (E 102).
Croatian: POPIS POMOĆNIH TVARI Također sadrži laktozu i tartrazin (E 102).
English: 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.
Croatian: U ispitivanju NOVA bolesnici pogodni za liječenje lijekom Zejula prije liječenja su imali sljedeće početne vrijednosti hematoloških parametara: apsolutni broj neutrofila (ABN) ≤ 1500 stanica/µl; trombocite ≤ 100 000/µl i hemoglobin ≤ 9 g/dl.
English: 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).
Croatian: Nakon primjene jednokratne oralne doze od 300 mg nirapariba, srednja vrijednost terminalnog poluvijeka (t½) nirapariba bila je u rasponu od 48 do 51 sata (približno 2 dana).
English: In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib was 16.2 L/h in cancer patients.
Croatian: U analizi populacijske farmakokinetike prividni ukupni klirens (CL/F) nirapariba bio je 16,2 l/h u bolesnika s rakom.
English: • Fast heart beat may cause dizziness, chest pain or breathlessness
Croatian: • brze otkucaje srca koji mogu uzrokovati omaglicu, bol u prsnom košu ili nedostatak zraka
English: • Resume Zejula at a reduced dose (100 mg/day).
Croatian: • Nastavite primjenu lijeka Zejula sa smanjenom dozom (100 mg/dan).
English: The recommended dose reductions are first from three hard capsules daily (300 mg) to two hard capsules daily (200 mg).
Croatian: Prvo se preporučuje smanjenje doze s tri tvrde kapsule dnevno (300 mg) na dvije tvrde kapsule dnevno (200 mg).
English: In vitro, niraparib inhibits P-gp very weakly and BCRP with an IC50 = 161 µM and 5.8 µM, respectively.
Croatian: In vitro, niraparib vrlo slabo inhibira P-gp s IC50 = 161 µM, odnosno BCRP s IC50 = 5,8 µM.
English: • Bruising or bleeding for longer than usual if you hurt yourself -- these may be signs of a low blood platelet count (thrombocytopenia).
Croatian: • Nastanak modrica ili krvarenje nakon ozljede koje traje dulje nego uobičajeno - to mogu biti znakovi niskog broja trombocita (trombocitopenije).
English: A pregnancy test should be performed on all women of childbearing potential prior to treatment.
Croatian: Prije početka liječenja u svih žena reproduktivne dobi treba provesti test na trudnoću.
English: CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered Zejula 100 mg/day
Croatian: Nuspojava povezana s liječenjem ≤ 3. stupnja prema CTCAE*, prisutna dulje od 28 dana dok bolesnik primjenjuje lijek Zejula u dozi od 100 mg/dan
English: Diarrhoea, constipation, mucosal inflammation (including mucositis), stomatitis, dry mouth
Croatian: Proljev, konstipacija, upala sluznica (uključujući mukozitis), stomatitis, suhoća usta
English: Approximately 50 % of patients experienced anaemia of any grade, and 25 % experienced Grade 3/4 anaemia.
Croatian: U otprilike 50 % bolesnika došlo je do anemije bilo kojeg stupnja, a u 25 % bolesnika došlo je do anemije 3./4. stupnja.
English: • Permanently discontinue Zejula.
Croatian: Trajno prekinite primjenu lijeka Zejula.
English: Patients began treatment on Cycle 1/Day 1 (C1/D1) with niraparib 300 mg or matched placebo administered QD in continuous 28-day cycles.
Croatian: Bolesnici su na 1.dan 1. ciklusa započeli liječenje niraparibom u dozi od 300 mg ili odgovarajućim placebom primijenjenima jednom dnevno u neprekidnim ciklusima od 28 dana.
English: Zejula lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia).
Croatian: Zejula snižava broj krvnih stanica, kao što su broj crvenih krvnih stanica (anemija), broj bijelih krvnih stanica (neutropenija) ili broj krvnih pločica (trombocitopenija).
English: There are no data in patients with severe hepatic impairment; use with caution in these patients (see section 5.2).
Croatian: Nema podataka o bolesnicima s teškim oštećenjem funkcije jetre; u tih bolesnika oprezno primjenjujte lijek (vidjeti dio 5.2).
English: • Elevated blood tests
Croatian: • povišene nalaze u krvi
English: 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.
Croatian: U približno 76 % bolesnika s manjim početnim brojem trombocita (< 180 × 109/L) koji su primali lijek Zejula došlo je do trombocitopenije bilo kojeg stupnja, a u 45 % tih bolesnika došlo je do trombocitopenije 3./4. stupnja.
English: In the HRDpos group, the hazard ratio was 0.38 (95 % CI, 0.243, 0.586; p < 0.0001).
Croatian: U skupini HRDpoz omjer hazarda bio je 0,38 (CI 95 % 0,243; 0,586; p < 0,0001).
English: Table 4 shows the results for the PFS primary endpoint for the primary efficacy populations (gBRCAmut cohort and the overall non-gBRCAmut cohort).
Croatian: Tablica 4 prikazuje rezultate PFS-a kao mjere primarnog ishoda u populacijama u kojima je provedena primarna analiza djelotvornosti (gBRCAmut skupina i cijela non-gBRCAmut skupina).
English: • Resume Zejula at a reduced dose (200 mg/day).
Croatian: • Nastavite primjenu lijeka Zejula sa smanjenom dozom (200 mg/dan).
English: If a patient develops severe persistent haematologic toxicity that does not resolve within 28 days following interruption, Zejula should be discontinued.
Croatian: Ako se u bolesnika razvije teška perzistentna hematološka toksičnost koja se ne povuče unutar 28 dana od prekida, liječenje lijekom Zejula treba se prekinuti.
English: 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).
Croatian: Više je bolesnika nastavilo liječenje dulje od 12 mjeseci u skupini s niraparibom (54,4 %) nego u skupini s placebom (16,9 %).
English: 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).
Croatian: Stoga se preporučuje oprez kad se niraparib kombinira s djelatnim tvarima čiji je metabolizam ovisan o CYP3A4, a pogotovo onima s uskom terapijskom širinom (npr. ciklosporin, takrolimus, alfentanil, ergotamin, pimozid, kvetiapin i halofantrin).
English: Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy.
Croatian: U slučaju hipertenzivne krize ili ako se medicinski značajna hipertenzija ne može odgovarajuće kontrolirati antihipertenzivnim liječenjem, liječenje lijekom Zejula treba prekinuti.
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit (e.g. itraconazole, ritonavir, and clarithromycin) or induce CYP enzymes (e.g. rifampin, carbamazepine, and phenytoin).
Croatian: Nije potrebna prilagodba doze lijeka Zejula kad se primjenjuje istodobno s lijekovima za koje je poznato da inhibiraju (npr. itrakonazol, ritonavir i klaritromicin) ili induciraju CYP enzime (npr. rifampicin, karbamazepin i fenitoin).
English: • Low potassium levels in the blood
Croatian: • niske razine kalija u krvi
English: Taking Zejula at bedtime may help you to manage nausea.
Croatian: Uzimanje lijeka Zejula prije spavanja može pomoći u sprečavanju mučnine.
English: Non-haematologic CTCAE* ≥ Grade 3 treatment-related adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment
Croatian: Tablica 1: Modifikacije doza zbog nehematoloških nuspojava Nehematološka nuspojava ≤ 3. stupnja prema CTCAE* povezana s liječenjem za koju se smatra da profilaksa nije moguća ili je ta nuspojava i dalje prisutna unatoč liječenju
English: 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.
Croatian: Lijek Zejula indiciran je u monoterapiji kao terapija održavanja u odraslih bolesnika s relapsom seroznog karcinoma jajnika, jajovoda ili primarno peritoneuma koji je visokog stupnja, osjetljiv na platinu i u odgovoru (potpunom ili djelomičnom) na kemoterapiju koja sadrži platinu.
English: 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).
Croatian: U cijeloj non-gBRCAmut skupini je medijan broja ciklusa liječenja bio veći u grani s niraparibom (8 ciklusa) nego u grani s placebom (5 ciklusa).
English: Capsule content Magnesium stearate
Croatian: Sadržaj kapsule magnezijev stearat laktoza hidrat
English: • Withhold Zejula for a maximum of 28 days or until resolution of adverse reaction.
Croatian: • Prekinite primjenu lijeka Zejula na najviše 28 dana ili dok se nuspojava ne povuče.
English: 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).
Croatian: Stoga se preporučuje oprez kad se niraparib kombinira s djelatnim tvarima čiji je metabolizam ovisan o CYP1A2, a pogotovo onima s uskom terapijskom širinom (npr. klozapin, teofilin i ropinirol).
English: Chemotherapy-free interval Median (95 % CI) - mo
Croatian: razdoblje bez kemoterapije medijan (95 % CI) - mo
English: In the clinical programme, anaemia was managed with laboratory monitoring, dose modification (see section 4.2), and where appropriate with red blood cell transfusions.
Croatian: U kliničkom programu anemija je bila zbrinuta praćenjem laboratorijskih nalaza, modifikacijom doze (vidjeti dio 4.2) i transfuzijom crvenih krvnih stanica kada je bilo primjereno.
English: How to store Zejula
Croatian: Kako čuvati lijek Zejula
English: In the clinical programme, neutropenia was managed with laboratory monitoring and dose modifications (see section 4.2).
Croatian: U kliničkom programu neutropenija je bila zbrinuta praćenjem laboratorijskih nalaza i modifikacijom doze (vidjeti dio 4.2).
English: How to take Zejula
Croatian: Kako uzimati lijek Zejula
English: 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.
Croatian: U analizi populacijske farmakokinetike prema podacima iz kliničkih ispitivanja na bolesnicima, prethodno postojeće blago i umjereno oštećenje funkcije jetre nije utjecalo na klirens nirapariba.
English: 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).
Croatian: PFS after the first subsequent therapy, PFS2), vrijeme do druge sljedeće terapije (engl. time to second subsequent therapy, TSST) i ukupno preživljenje (engl. overall survival, OS).
English: 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).
Croatian: Više je bolesnika nastavilo liječenje dulje od 12 mjeseci u skupini s niraparibom (34,2 %) nego u skupini s placebom (21,1 %).
English: 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).
Croatian: U gBRCAmut skupini je medijan broja ciklusa liječenja bio veći u grani s niraparibom (14 ciklusa) nego u grani s placebom (7 ciklusa).
English: Reduced locomotor activity was seen in one of two single dose studies in mice.
Croatian: U jednom od dva ispitivanja jednokratnih doza u miševa zapažena je smanjena lokomotorna aktivnost.
English: 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).
Croatian: Antikoagulanse i lijekove za koje je poznato da smanjuju broj trombocita treba primjenjivati uz oprez zbog rizika od trombocitopenije (vidjeti dio 4.8).
English: • Inflammation of the mouth and/or digestive tract
Croatian: • upalu usne šupljine i/ili probavnog sustava
English: Thrombocytopenia, anaemia, neutropenia
Croatian: Trombocitopenija, anemija, neutropenija
English: Patients who take Zejula may experience asthenia, fatigue and dizziness.
Croatian: U bolesnika koji uzimaju lijek Zejula može doći do astenije, umora i omaglice.
English: No dose adjustment is needed in patients with mild to moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: Brilliant blue FCF (E 133) Erythrosine (E 127) Tartrazine (E 102)
Croatian: Ovojnica kapsule titanijev dioksid (E 171) želatina brilliant blue FCF (E 133) eritrozin (E 127) tartrazin (E 102)
English: Myelodysplastic syndrome/acute myeloid leukaemia Rarely, low blood-cell counts may be a sign of more serious problems with the bone marrow such as
Croatian: Mijelodisplastični sindrom / akutna mijeloična leukemija Rijetko, nizak broj krvnih stanica može biti znak ozbiljnijih problema s koštanom srži kao što su mijelodisplastični sindrom (MDS) ili akutna mijeloična leukemija (AML).
English: In addition, Granulocyte-Colony Stimulating Factor (G-CSF) was administered to approximately 6 % of patients treated with niraparib as concomitant therapy for neutropenia.
Croatian: Osim toga je u približno 6 % bolesnika liječenih niraparibom kao istodobna terapija za neutropeniju primijenjen faktor stimulacije granulocitnih kolonija (GCSF).
English: • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥ 1,500/µL or haemoglobin returns to ≥ 9 g/dL.
Croatian: Prekinite primjenu lijeka Zejula na najviše 28 dana i tjedno pratite krvnu sliku dok se broj neutrofila ne vrati na ≤ 1500/µl ili dok se hemoglobin ne vrati na ≤ 9 g/dl.
English: There are no data in patients with severe renal impairment or end stage renal disease undergoing haemodialysis; use with caution in these patients (see section 5.2).
Croatian: Nema podataka za bolesnike s teškim oštećenjem funkcije bubrega ili u završnom stadiju bubrežne bolesti koji se podvrgavaju hemodijalizi; u tih bolesnika oprezno primjenjujte lijek (vidjeti dio 5.2).
English: Nausea, vomiting, abdominal pain
Croatian: Mučnina, povraćanje, abdominalna bol Manje često
English: What Zejula is and what it is used for What Zejula is and how it works
Croatian: Što je Zejula i kako djeluje
English: • 56 × 1 hard capsules
Croatian: • 56 × 1 tvrda kapsula
English: The median time to onset of neutropenia of any grade was 27 days, and 29 days for Grade 3/4 events.
Croatian: Medijan vremena do nastupa neutropenije bilo kojeg stupnja bio je 27 dana, a za slučajeve 3./4. stupnja 29 dana.
English: B: Placebo
Croatian: Zejula placebo
English: Zejula 100 mg hard capsules niraparib
Croatian: Zejula 100 mg tvrde kapsule niraparib