FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of niraparib have not been assessed in patients with severe hepatic impairment (see section 4.2).
Slovenian: Farmakokinetike nirapariba niso ocenili pri bolnicah s hudo okvaro jeter (glejte poglavje 4.2).
English: In the case that the adverse reaction recurs, it is recommended to reduce the dose.
Slovenian: Če se neželeni učinek ponovi, je odmerek priporočljivo zmanjšati.
English: Niraparib is metabolised primarily by carboxylesterases (CEs) to form a major inactive metabolite, M1.
Slovenian: Niraparib primarno presnavljajo karboksilesteraze (CE), pri čemer nastaja glavni neaktivni presnovek, M1.
English: In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib was 16.2 L/h in cancer patients.
Slovenian: V analizi populacijske farmakokinetike je bil navidezni celotni očistek (CL/F) nirapariba pri bolnicah z rakom 16,2 l/h.
English: Following multiple oral doses of niraparib from 30 mg to 400 mg once daily, accumulation of niraparib was approximately 2 to 3 folds.
Slovenian: Po večkratnih peroralnih odmerkih od 30 mg do 400 mg nirapariba enkrat dnevno je bilo kopičenje nirapariba približno 2- do 3-kratno.
English: Frequency of all CTCAE grades
Slovenian: Pogostnost vseh stopenj po
English: In vitro, niraparib weakly induces CYP1A2 at high concentrations and the clinical relevance of this effect would not be completely ruled out.
Slovenian: Niraparib in vitro v visokih koncentracijah šibko inducira CYP1A2 in kliničnega pomena tega ni mogoče povsem izključiti.
English: TESARO Bio GERMANY GmbH
Slovenian: Deutschland TESARO Bio GERMANY GmbH
English: • Feelings of sadness, depressed
Slovenian: • občutek žalosti, depresivnosti,
English: In vitro, niraparib inhibited the dopamine transporter DAT at concentration levels below human exposure levels.
Slovenian: Niraparib je in vitro zaviral dopaminski prenašalec DAT pri koncentracijah, nižjih od ravni izpostavljenosti pri človeku.
English: In a population pharmacokinetic analysis of niraparib, the Vd/F was 1,074 L in cancer patients, indicating extensive tissue distribution of niraparib.
Slovenian: V analizi populacijske farmakokinetike nirapariba je bil Vd/F pri bolnicah z rakom 1,074 l, kar kaže na obsežno porazdelitev nirapariba po tkivih.
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.
Slovenian: V študiji NOVA so bolnice, primerne za zdravljenje z zdravilom Zejula, imele naslednje izhodiščne hematološke parametre: absolutno število nevtrofilcev (ANC, absolute neutrophil count) ≥ 1,500 celic/µl; trombociti ≥ 100.000 celic/µl in hemoglobin ≥ 9 g/dl pred zdravljenjem.
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).
Slovenian: Sekundarni opazovani dogodki CFI, TFST in PFS2 so pokazali statistično značilen in dolgotrajen učinek zdravljenja v korist kraka zdravljenja z niraparibom v kohorti gBRCAmut in celotni kohorti ne-gBRCAmut (preglednica 5).
English: • Fast heart beat may cause dizziness, chest pain or breathlessness
Slovenian: • hitro bitje srca lahko povzroči omotičnost, bolečino v prsih ali pomanjkanje sape,
English: Your doctor will ask you to confirm that you are not pregnant with a pregnancy test before starting your treatment.
Slovenian: Pred začetkom zdravljenja vas bo zdravnik prosil, da s testom nosečnosti potrdite, da niste noseči.
English: After the first month, it is recommended to monitor CBCs monthly and periodically after this time (see section 4.4).
Slovenian: Po prvem mesecu je priporočljivo vsakomesečno spremljanje CKS, po tem pa periodično (glejte poglavje 4.4).
English: A possible cause for sepsis is a low neutrophil count and there is a potential association between niraparib and developing sepsis.
Slovenian: Možen vzrok sepse je majhno število nevtrofilcev, zato obstaja možna povezava med niraparibom in razvojem sepse.
English: What you need to know before you take Zejula Do not take Zejula
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zejula Ne jemljite zdravila Zejula
English: Patients treated with Zejula who develop thrombocytopenia might have an increased risk of haemorrhage.
Slovenian: Bolnice, zdravljene z zdravilom Zejula, pri katerih se razvije trombocitopenija, so lahko izpostavljene višjemu tveganju krvavitve.
English: (12.9, NR)
Slovenian: (12,9, ND)
English: • Bruising or bleeding for longer than usual if you hurt yourself -- these may be signs of a low blood platelet count (thrombocytopenia).
Slovenian: • Modrica ali krvavitev, ki je prisotna dlje kot običajno, če se poškodujete - to je lahko znak nizkega števila krvnih ploščic (trombocitopenija).
English: Blood pressure should be monitored monthly for the first year and periodically thereafter during treatment with Zejula.
Slovenian: Med zdravljenjem z zdravilom Zejula je treba prvo leto spremljati krvni tlak enkrat mesečno, nato pa periodično.
English: (17.5-NR)
Slovenian: (17,5-ND)
English: Niraparib is an inhibitor of MATE1 and -2 with IC50 of 0.18 µM and ≤ 0.14 µM, respectively.
Slovenian: Niraparib je zaviralec MATE1 in MATE2 z IC50 0,18 µM oziroma ≤ 0,14 µM.
English: 84 × 1 hard capsules 56 × 1 hard capsules 28 × 1 hard capsules
Slovenian: 84 × 1 trda kapsula 56 × 1 trda kapsula 28 × 1 trda kapsula
English: Breast-feeding is contraindicated during administration of Zejula and for 1 month after receiving the last dose (see section 4.3).
Slovenian: Dojenje je kontraindicirano med dajanjem zdravila Zejula in še 1 mesec po prejemu zadnjega odmerka (glejte poglavje 4.3).
English: What Zejula looks like and contents of the pack
Slovenian: Izgled zdravila Zejula in vsebina pakiranja
English: To be eligible for niraparib treatment, the patient should be in response (CR or PR) following completion of last platinum based chemotherapy.
Slovenian: Da so bile primerne za zdravljenje z niraparibom, so bolnice morale imeti odziv (PO ali DO) po zaključku zadnje kemoterapije na osnovi platine.
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).
Slovenian: • Druge sestavine zdravila (pomožne snovi) so: vsebina kapsule: magnezijev stearat, laktoza monohidrat; ovojnica kapsule: titanov dioksid (E 171), želatina, barvilo modro FCF (E 133), eritrozin (E 127), tartrazin (E 102); tiskarsko črnilo: šelak (E 904), propilenglikol (E 1520), kalijev hidroksid (E 525), črni železov oksid (E 172), natrijev hidroksid (E 524) in povidon (E 1201).
English: A concomitant high-fat meal did not significantly affect the pharmacokinetics of niraparib after administration of 300 mg of niraparib.
Slovenian: Sočasen obrok z veliko maščobe ni znatno vplival na farmakokinetiko nirapariba po dajanju 300 mg nirapariba.
English: Table 4: Summary of primary objective outcomes in the ENGOT-OV16 study gBRCAmut cohort
Slovenian: Preglednica 4: Povzetek izidov primarnega cilja v študiji ENGOT-OV16 Kohorta gBRCAmut Kohorta ne-gBRCAmut niraparib
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih vrst sladkorja, se pred jemanjem tega zdravila posvetujte z njim.
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.
Slovenian: Zaviranje CYP (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4) Niraparib in M1 nista zaviralca nobenega encima CYP, ki sodeluje pri presnovi učinkovin, torej CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4/5.
English: bronchitis
Slovenian: bronhitis
English: • For patients with platelet count ≤ 10,000/μL, platelet transfusion should be considered.
Slovenian: Pri bolnicah s številom trombocitov ≤ 10.000/μl je treba razmisliti o transfuziji trombocitov.
English: Oedema peripheral
Slovenian: Pogosti periferni edem
English: Some of the patients had a history of bone marrow dysplasia.
Slovenian: Nekatere bolnice so imele anamnezo displazije kostnega mozga.
English: 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.
Slovenian: Iz združenih vzorcev, zbranih v 6 dneh, je bilo iz urina pridobljenega 40,0 % odmerka primarno v obliki presnovkov, 31,6 % odmerka pa je bilo pridobljenega iz blata,
English: Patients who take Zejula may experience asthenia, fatigue and dizziness.
Slovenian: Pri bolnicah, ki jemljejo zdravilo Zejula, se lahko pojavijo astenija, utrujenost in omotičnost.
English: TESARO Bio Sweden AB
Slovenian: Sverige TESARO Bio Sweden AB
English: In mice, single doses of niraparib increased intracellular levels of dopamine and metabolites in cortex.
Slovenian: Pri miših so enkratni odmerki nirapariba zvišali medcelične ravni dopamina in presnovkov v korteksu.
English: Treatment A: Niraparib
Slovenian: niraparib
English: • Elevated blood tests
Slovenian: • zvišani rezultati krvnih preiskav,
English: • Resume Zejula at same or reduced dose based on clinical evaluation.
Slovenian: Ponovno začnite zdravljenje z zdravilom Zejula z enakim ali zmanjšanim odmerkom, skladno s klinično presojo.
English: Figure 1: Kaplan-Meier plot for progression-free survival in the gBRCAmut cohort based on IRC assessment (ITT population, N = 203)
Slovenian: Slika 1: Kaplan-Meierjev grafikon za preživetje brez napredovanja bolezni v kohorti gBRCAmut na osnovi ocene IRC (populacija ITT, N = 203)
English: The major primary metabolite M1 is not a substrate of P-gp, BCRP, or BSEP.
Slovenian: Glavni primarni presnovek M1 ni substrat P-gp, BCRP ali BSEP.
English: Zejula should not be used during pregnancy.
Slovenian: Zdravila Zejula ne smete uporabljati pri nosečnicah.
English: There are no or limited amount of data from the use of niraparib in pregnant women.
Slovenian: Podatkov o uporabi nirapariba pri nosečnicah ni oziroma so omejeni.
English: Do not take an additional dose if you miss a dose or vomit after taking Zejula.
Slovenian: Ne vzemite dodatnega odmerka, če ste pozabili vzeti prejšnji odmerek ali če ste bruhali po jemanju zdravila Zejula.
English: Non-haematologic CTCAE* ≥ Grade 3 treatment-related adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment
Slovenian: 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
English: If patients miss a dose, they should take their next dose at its regularly scheduled time.
Slovenian: Izpuščeni odmerek Če bolnica izpusti odmerek, naj vzame svoj naslednji odmerek ob naslednjem času skladno z načrtom jemanja zdravila.
English: Reduced locomotor activity was seen in one of two single dose studies in mice.
Slovenian: V eni od dveh študij z enkratnim odmerkom pri miših so opazili zmanjšano lokomotorično aktivnost.
English: Your doctor will test your blood regularly throughout your treatment.
Slovenian: Med zdravljenjem bo zdravnik redno izvajal preiskave vaše kri.
English: • 84 × 1 hard capsules
Slovenian: • 84 × 1 trdo kapsulo
English: Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair.
Slovenian: Niraparib je zaviralec poli-(ADP-riboza) polimeraz (PARP), in sicer PARP1 in PARP2, ki imata vlogo pri popravljanju poškodb DNA.
English: 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 %.
Slovenian: Stopnja novih incidenc trombocitopenije po intenzivnih prilagajanjih odmerkov, ki so bila izvedena v prvih dveh mesecih zdravljenja od
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 %)].
Slovenian: 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 %)].
English: 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.
Slovenian: 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.
English: Table 3: Adverse drug reactions: frequencies based on all-causality adverse events* System Organ Class
Slovenian: Preglednica 3: Neželeni učinki zdravila: pogostnosti na osnovi neželenih dogodkov vseh vzrokov*
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.
Slovenian: 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.
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of niraparib in paediatric patients.
Slovenian: Pediatrična populacija Študije za raziskavo farmakokinetike nirapariba pri pediatričnih bolnicah niso bile izvedene.
English: Median ages ranged from 57 to 63 years across treatments and cohorts.
Slovenian: Mediane starosti so se v skupinah zdravljenja in kohortah gibale od 57 to 63 let.
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.
Slovenian: 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.
English: Neither niraparib nor M1 is a CYP3A4 inducer in vitro.
Slovenian: Niraparib in M1 in vitro nista induktorja CYP3A4.
English: Second occurrence:
Slovenian: Drugi pojav:
English: Median (95 % CI) - mo
Slovenian: Mediani (95-% IZ) - mo
English: Figure 2: Kaplan-Meier plot for progression-free survival in the non-gBRCAmut cohort overall based on IRC assessment (ITT population, N = 350)
Slovenian: Slika 2: Kaplan-Meierjev grafikon za preživetje brez napredovanja bolezni v celotni kohorti ne-gBRCAmut na osnovi ocene IRC (populacija ITT, N = 350)
English: In vitro, niraparib weakly inhibits the organic cation transporter 1 (OCT1) with an IC50 = 34.4 µM.
Slovenian: Niraparib in vitro šibko zavira organski kationski prenašalec 1 (OCT1) z IC50 = 34,4 µM.
English: Taking Zejula at bedtime may help you to manage nausea.
Slovenian: Če zdravilo Zejula jemljete pred spanjem, vam to lahko pomaga obvladati siljenje na bruhanje.
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).
Slovenian: 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).
English: Approximately 50 % of patients experienced anaemia of any grade, and 25 % experienced Grade 3/4 anaemia.
Slovenian: Pri približno 50 % bolnic se je pojavila anemija katere koli stopnje, pri 25 % bolnic pa se je pojavila anemija 3. ali 4. stopnje.
English: Discontinuation due to thrombocytopenia events (thrombocytopenia and platelet count decreased) occurred in approximately 3 % of the patients.
Slovenian: Do ukinitve zdravljenja zaradi dogodkov trombocitopenije (trombocitopenije in znižanega števila trombocitov) je prišlo pri približno 3 % bolnic.
English: Caution is recommended when niraparib is combined with active substances that undergo an uptake transport by OCT1 such as metformin.
Slovenian: Pri kombiniranju nirapariba z učinkovinami, ki so podvržene privzemnemu prenosu z OCT1, kot je na primer metformin.
English: Thrombocytopenia occurred more commonly in patients whose baseline platelet count was less than 180 × 109/L.
Slovenian: Trombocitopenija se je pogosteje pojavila pri bolnicah z izhodiščnim številom trombocitov manj kot 180 × 109/l.
English: Chemotherapy-free interval Median (95 % CI) - mo
Slovenian: Interval brez kemoterapije Mediani (95-% IZ) - mo
English: • 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.
Slovenian: 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.
English: Haematologic adverse reaction requiring transfusion or haematopoietic growth factor support
Slovenian: zaradi katerih je potrebna podpora s transfuzijo ali hematopoetskimi rastnimi faktorji
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.
Slovenian: 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.
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.
Slovenian: 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.
English: In addition, Granulocyte-Colony Stimulating Factor (G-CSF) was administered to approximately 6 % of patients treated with niraparib as concomitant therapy for neutropenia.
Slovenian: Poleg tega je približno 6 % bolnic, zdravljenih z niraparibom, prejelo rastne faktorje granulocitne vrste (G-CSF) kot sočasno terapijo za nevtropenijo.
English: Talk to your doctor, pharmacist or nurse before or while taking this medicine if any of the following could apply to you:
Slovenian: 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:
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).
Slovenian: Več bolnic v skupini z niraparibom kot v skupini s placebom je nadaljevalo zdravljenje več kot 12 mesecev (34,2 % oziroma 21,1 %).
English: Caution is then recommended when niraparib is combined with substrates of BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin, and methotrexate).
Slovenian: Zato je priporočljiva previdnost pri kombiniranju nirapariba s substrati BCRP (irinotekan, rosuvastatin, simvastatin,
English: (17.9-NR)
Slovenian: (17,9-ND)
English: Platelet count < 100,000/μL
Slovenian: Število trombocitov < 100.000/μl
English: Zejula can be taken without regard to meals.
Slovenian: Zdravilo Zejula je mogoče jemati s hrano ali brez nje.
English: 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).
Slovenian: 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
English: What Zejula is and what it is used for What Zejula is and how it works
Slovenian: Kaj je zdravilo Zejula in kako deluje
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).
Slovenian: Zaradi tveganja za trombocitopenijo je potrebna previdnost pri uporabi antikoagulantov in zdravil, za katera je znano, da zmanjšujejo število trombocitov (glejte poglavje 4.8).
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).
Slovenian: 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).
English: Discontinuation due to neutropenia events occurred in 2 % of patients.
Slovenian: Do ukinitve zdravljenja zaradi dogodkov nevtropenije je prišlo pri 2 % bolnic.
English: Myelodysplastic syndrome/acute myeloid leukaemia
Slovenian: Mielodisplastični sindrom/akutna mieloična levkemija
English: 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).
Slovenian: 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).
English: Package leaflet: Information for the patient Zejula 100 mg hard capsules niraparib This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Zejula 100 mg trde kapsule niraparib Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Therefore, caution should be taken if niraparib is used in combination with vaccines, immunosuppressant agents or with other cytotoxic medicinal products.
Slovenian: Zato je pri uporabi nirapariba v kombinaciji s cepivi, imunosupresivi ali drugimi citotoksičnimi zdravili potrebna previdnost.
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.
Slovenian: V analizi populacijske farmakokinetike podatkov iz kliničnih študij pri bolnicah predhodno obstoječa blaga in zmerna okvara jeter ni vplivala na očistek nirapariba.
English: Inhibition of efflux transporters (P-gp, BCRP, BSEP, and MATE1/2) Niraparib is not an inhibitor of BSEP.
Slovenian: Zaviranje izločevalnih prenašalcev (P-gp, BCRP, BSEP in MATE 1/2) Niraparib ni zaviralec BSEP.