natgillin/translations-raw huggingface dataset:
This medicine contains lactose and tartrazine - see section 2 for more information.
To zdravilo vsebuje laktozo in tartrazin - za več informacij glejte poglavje 2.
This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of niraparib and indicates potential for genotoxicity in humans.
Ta klastogenost je konsistentna z genomsko nestabilnostjo, ki izhaja iz primarne farmakologije nirapariba in kaže na potencial za genotoksičnost pri ljudeh.
The hard capsules are packed in blister packs of
Trde kapsule so pakirane v pretisne omote po
Ask your doctor for advice before taking this medicine.
Posvetujte se z zdravnikom, preden vzamete to zdravilo.
Women of childbearing potential should not become pregnant while on treatment and should not be pregnant at the beginning of treatment.
Ženske v rodni dobi med zdravljenjem ne smejo zanositi in ob začetku zdravljenja ne smejo biti noseče.
This medicinal product contains tartrazine (E 102), which may cause allergic reactions.
To zdravilo vsebuje tartrazin (E 102), ki lahko povzroči alergijske reakcije.
Following a signal regarding sepsis with niraparib, a number of relevant cases were identified.
Tekom obravnave varnostnega signala v zvezi s sepso za niraparib je bilo ugotovljenih več relevantnih primerov.
The capsules should not be chewed or crushed.
Kapsul se ne sme žvečiti ali zdrobiti.
Observe caution when driving or using machines.
Pri vožnji ali upravljanju strojev bodite previdni.
Hypertension of any grade occurred in 19.3 % of patients treated with Zejula.
Hipertenzija katere koli stopnje se je pojavila pri 19,3 % bolnic, zdravljenih z zdravilom Zejula.
Niraparib is not a substrate of MATE 1 or 2, while M1 is a substrate of both.
Niraparib ni substrat MATE 1 ali 2, medtem ko je M1 substrat obeh.
• Palpitations (feeling like your heart is skipping beats or beating harder than usual)
• okužba sečil, • palpitacije (občutek, da srce preskakuje utripe ali da bije močneje kot ponavadi),
Swallow the capsules whole, with some water.
Kapsule pogoltnite cele, z nekaj vode.
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.
Preživetje brez napredovanja bolezni (PFS - progression-free survival) je bilo ugotovljeno po merilih RECIST (Response Evaluation Criteria in Solid Tumors, različica 1.1) ali na osnovi kliničnih znakov in simptomov in zvišanega CA125.
Niraparib can cause haematological toxicity that includes febrile neutropenia.
Niraparib lahko povzroči hematološko toksičnost, ki vključuje febrilno nevtropenijo.
The recommended dose modifications for adverse reactions are listed in Tables 1 and 2.
Priporočene prilagoditve odmerka za posamezne neželene učinke so navedene v preglednicah 1 in 2.
The capsules should be swallowed whole with water.
Kapsule je treba pogoltniti cele z vodo.
Zejula should not be taken during pregnancy as it could harm your baby.
Zdravila Zejula ne smete jemati med nosečnostjo, saj bi lahko škodilo vašemu otroku.
There is no specific treatment in the event of Zejula overdose, and symptoms of overdose are not established.
Specifičnega zdravljenja v primeru prevelikega odmerjanja zdravila Zejula ni, simptomi prevelikega odmerjanja pa še niso ugotovljeni.
Frequency of CTCAE grade 3 or 4
Pogostnost stopenj 3 ali 4 po
Induction of CYPs (CYP1A2 and CYP3A4)
Spodbujanje CYP (CYP1A2 in CYP3A4)
Patients with ECOG performance status 2 to 4 Clinical data are not available in patients with ECOG performance status 2 to 4.
Bolnice z oceno zmogljivosti 2 do 4 po ECOG Kliničnih podatkov za bolnice z oceno zmogljivosti 2 do 4 po ECOG ni na voljo.
Even though inhibition of CYP3A4 in the liver is not expected, the potential to inhibit CYP3A4 at the intestinal level has not been established at relevant niraparib concentrations.
Čeprav zaviranje CYP3A4 v jetrih ni pričakovano, potencial za zaviranje CYP3A4 na črevesni ravni pri relevantnih koncentracijah nirapariba še ni bil ugotovljen.
Approximately 47 % of patients restarted at a reduced dose in Cycle 2.
Približno 47 % bolnic je v 2. ciklu ponovno začelo zdravljenje z zmanjšanim odmerkom.
In the clinical programme, blood pressure measurements were obtained on Day 1 of each 28-day cycle while the patient remained on Zejula.
V kliničnem programu so meritve krvnega tlaka izvajali 1. dan vsakega 28-dnevnega cikla, dokler je bila bolnica zdravljena z zdravilom Zejula.
The most common serious adverse reactions > 1 % (treatment-emergent frequencies) were thrombocytopenia and anaemia.
Najpogostejša resna neželena učinka > 1 % (pogostnosti pojavljanja med zdravljenjem) sta bila trombocitopenija in anemija.
Eligible patients were assigned to one of two cohorts based on the results of a germline BRCA mutation test.
Primerne bolnice so bile razporejene v eno od dveh kohort na osnovi rezultatov testa zarodne mutacije BRCA (germline BRCA mutation).
In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis and cell death.
Študije in vitro so pokazale, da citotoksičnost, ki jo spodbuja niraparib, morda vključuje zaviranje encimske aktivnosti PARP in povečano tvorbo kompleksov PARP-DNA, ki privedejo do poškodb DNA, apoptoze in celične smrti.
Effect of other medicinal products on niraparib
Učinki drugih zdravil na niraparib
Febrile neutropenia was reported in 2 out of 367 patients in the NOVA trial leading to the frequency uncommon.
O febrilni nevtropeniji so poročali pri 2 bolnikih od 367 bolnikov v preskušanju NOVA, zaradi česar je njena pogostnost označena kot občasna.
In the NOVA study, 48 % of patients had a dose interruption in Cycle 1.
V študiji NOVA je pri 48 % bolnic prišlo do prekinitve odmerjanja v 1. ciklu.
Other medicines and Zejula
Druga zdravila in zdravilo Zejula
Most patients were age 18 to 64 years (78 %), Caucasian (86 %) and had an ECOG performance status of 0 (68 %).
Večina bolnic je bila starih od 18 do 64 let (78 %), belk (86 %) in je imela oceno zmogljivosti 0 po ECOG
If MDS and/or AML are confirmed while on treatment with Zejula, treatment should be discontinued and the patient treated appropriately.
Če sta med zdravljenjem z zdravilom Zejula potrjena MDS in/ali AML, je treba zdravljenje ukiniti in bolnico ustrezno zdraviti.
He or she may also give you medicine to treat high blood pressure and adjust your Zejula dose, if necessary.
Morda vam bo tudi dal zdravilo za zdravljenje visokega krvnega tlaka in po potrebi prilagodil vaš odmerek zdravila Zejula.
In the pivotal Phase 3 international trial (ENGOT-OV16), the incidence of MDS/AML in patients who received niraparib (1.4 %) was similar to that in patients who received placebo (1.1 %).
V osrednjem mednarodnem preskušanju 3. faze (ENGOT-OV16) je bila pojavnost MDS/AML pri bolnicah, ki so prejele niraparib (1,4 %), podobna kot pri bolnicah, ki so prejele placebo (1,1 %).
Take Zejula at approximately the same time each day.
Zdravilo Zejula vedno vzemite ob približno istem času dneva.
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 podlagi znanstvenih zaključkov za niraparib odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) niraparib nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
• Feeling of weakness
• občutek slabotnosti,
Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine.
Znaki lahko vključujejo vročino, mrzlico, občutek slabotnosti ali zmedenosti, kašelj, bolečino ali pekoč občutek pri uriniranju.
• Feeling of worry, nervousness, or unease
• občutek zaskrbljenosti, živčnosti ali nelagodja,
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).
Randomizacija znotraj vsake kohorte je bila stratificirana po času do napredovanja po predzadnji terapiji s platino pred vključitvijo v študijo (6 do < 12 mesecev in ≥ 12 mesecev), uporabi ali neuporabi bevacizumaba v povezavi s predzadnjim ali zadnjim režimom s platino ter najboljšem odzivu med zadnjim režimom s platino (popoln odziv in delni odziv).
Grade 3/4 hypertension occurred in 8.2 % of patients.
Hipertenzija 3. ali 4. stopnje se je pojavila pri 8,2 % bolnic.
p-value Hazard ratio (HR)
vrednost p razmerje tveganja (HR - hazard ratio)
Pancytopenia has been observed in < 1 % of patients receiving niraparib.
Pancitopenijo so opazili pri < 1 % bolnic, ki so prejemale niraparib.
It is unknown whether niraparib or its metabolites are excreted in human milk.
Ni znano, ali se niraparib ali njegovi presnovki izločajo v materino mleko.
Recommendations for the management of adverse reactions are provided in Table 1.
Priporočila za obvladovanje neželenih učinkov so podana v preglednici 1.
Therefore, a clinically meaningful interaction related to an inhibition of these efflux transporters although unlikely, cannot be excluded.
Zato klinično pomembnega medsebojnega delovanja v povezavi z zaviranjem teh izlivnih prenašalcev ni mogoče izključiti, čeprav je malo verjetno.
gBRCAmut non-gBRCAmut
gBRCAmut ne-gBRCAmut
Brilliant blue FCF (E 133) Erythrosine (E 127) Tartrazine (E 102)
želatina briljantno modro FCF (E 133) eritrozin (E 127) tartrazin (E 102)
The combination of niraparib with vaccines or immunosuppressant agents has not been studied.
Kombinacije nirapariba s cepivi ali imunosupresivi niso proučili.
Effect of niraparib on other medicinal products
Učinek nirapariba na druga zdravila
The cases were typical of secondary, cancer therapy-related MDS/AML.
Primeri so bili značilni za sekundarna, z zdravljenjem proti raku povezana MDS/AML.
PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP).
Zaviralci PARP blokirajo encim, ki mu pravimo poli-[adenozin-difosfat-riboza] polimeraza (PARP).
Radioactive recovery in the urine accounted for 47.5 % (range 33.4 % to 60.2 %) and in the feces for 38.8 % (range 28.3 % to 47.0 %) of the dose.
Iz urina pridobljeni radioaktivni material je predstavljal 47,5 % (razpon od 33,4 % do 60,2 %) odmerka, iz blata pridobljeni pa 38,8 % (razpon od
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolnice z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
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.
Analiza primarne učinkovitosti za PFS je bila ugotovljena s slepim centralnim neodvisnim ocenjevanjem ter prospektivno opredeljena in ločeno ocenjena za kohorto gBRCAmut in kohorto ne-gBRCAmut.
Patients were assigned to the gBRCAmut cohort based on blood samples for gBRCA analysis that were taken prior to randomisation.
Bolnice so bile razporejene v kohorto gBRCAmut na osnovi vzorcev krvi za analizo, odvzetih pred randomizacijo.
The data on niraparib in combination with cytotoxic medicinal products are limited.
Podatki o niraparibu v kombinaciji s citotoksičnimi zdravili so omejeni.
Zejula can cause high blood pressure, which in some cases, could be severe.
Visok krvni tlak Zdravilo Zejula lahko povzroči visok krvni tlak, zvišanje je lahko v nekaterih primerih hudo.
In the clinical programme, hypertension was readily managed with anti-hypertensive medicinal products.
V kliničnem programu so hipertenzijo brez težav obvladovali z zdravili proti hipertenziji.
Take your next dose at its scheduled time.
Vzemite naslednji odmerek po običajnem razporedu.
Zejula should not be taken if you are breast-feeding as it is not known if it passes into breast milk.
Zdravila Zejula ne smete jemati med dojenjem, saj ni znano, ali se izloča v materino mleko.
• 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).
• Pomanjkanje sape, občutek hude utrujenosti, bleda koža ali hiter srčni utrip - to je lahko znak nizkega števila rdečih krvničk (anemija).
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.
Pred razkritjem študije so bili tumorji bolnic testirani na prisotnost HRD z eksperimentalnim testom HRD, ki ovrednoti tri posredna merila nestabilnosti genoma tumorja: izgubo heterozigotnosti, neravnovesje telomer med aleli (TAI, telomeric allelic imbalance) in tranzicije velikega obsega.
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).
chemotherapy-free interval), čas do prve naslednje terapije (TFST - time to first subsequent therapy), PFS po prvi naslednji terapiji (PFS2), čas do druge naslednje terapije (TSST - time to second subsequent therapy) in skupno preživetje (OS - overall survival).
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.
V osrednji študiji ENGOT-OV16 so bili neželeni učinki zdravila, ki so se pojavili pri ≥ 10 % bolnic, ki so prejemale monoterapijo z zdravilom Zejula, naslednji: navzea, trombocitopenija, utrujenost/astenija, anemija, zaprtje, bruhanje, bolečina v trebuhu, nevtropenija, nespečnost, glavobol, zmanjšan apetit, nazofaringitis, driska, dispneja, hipertenzija, dispepsija, bolečina v hrbtu, omotičnost, kašelj, okužba sečil, artralgija, palpitacije in disgevzija.
Niraparib is a type of anti-cancer medicine called a PARP inhibitor.
Niraparib je vrsta zdravila proti raku, ki mu pravimo zaviralec PARP.
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 delež bolnic v obeh krakih zdravljenja v obeh kohortah je predhodno prejel 3 ali več linij kemoterapije, vključno z 49 % in 34 % odstotki bolnic, zdravljenih z niraparibom v kohortah gBRCAmut oziroma ne-gBRCAmut.
Pancytopenia, febrile neutropenia
Občasni pancitopenija, febrilna nevtropenija
A reversible reduction of spermatogenesis was observed in rats and dogs (see section 5.3).
Pri podganah in psih so opazili reverzibilno zmanjšanje spermatogeneze (glejte poglavje 5.3).
Each hard capsule shell also contains the colouring agent tartrazine (E 102) [0.0172 mg].
Poleg tega ovojnica trde kapsule vsebuje barvilo tartrazin (E 102) [0,0172 mg].
In a mass balance study, M1 and M10 (the subsequently formed M1 glucuronides) were the major circulating metabolites.
V študiji masnega ravnovesja sta bila glavna presnovka v obtoku M1 in M10 (pozneje nastali glukuronidi M1).
Uncommon (may affect up to 1 in 100 people) • Reduction in the number of red blood cells, white blood cells and platelets
Občasni (pojavijo se lahko pri največ 1 od 100 bolnic): • znižanje števila rdečih krvničk, belih krvničk in krvnih ploščic.
• Inflammation or swelling of the air passages between the mouth and nose and the lungs,
• vnetje ali oteklost dihalnih poti med usti, nosom in pljuči, bronhitis,
If you forget to take Zejula
Če ste pozabili vzeti zdravilo Zejula
The recommended starting dose is 3 capsules taken together once a day (total daily dose of 300 mg), with or without food.
Priporočeni začetni odmerek so 3 kapsule, ki jih vzamete naenkrat, in sicer enkrat dnevno (skupni dnevni odmerek 300 mg), s hrano ali brez nje.
• Abnormal blood tests
• nenormalni rezultati krvnih preiskav.
Your doctor will measure your blood pressure regularly throughout your treatment.
Med zdravljenjem bo zdravnik redno meril vaš krvni tlak.
Only 13 % of low body weight patients remained at a dose of 300 mg beyond Cycle 3.
Samo 13 % bolnic z majhno telesno maso je po 3. ciklu še vedno prejemalo odmerek 300 mg.
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 mutacije tBRCA in pomanjkljivosti homologne rekombinacije (HRD) so izvedli s testom HRD na tumornih tkivih, odvzetih ob času prvotne diagnoze ali ob času relapsa.
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).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Zejula za vse podskupine pediatrične populacije pri karcinomu jajčnika (izvzeti so rabdomiosarkom in tumorji germinalnih celic).
Aclar/PVC/aluminium foil perforated unit dose blisters in cartons of 84 × 1, 56 × 1 and 28 × 1 hard capsules.
Perforirani pretisni omoti iz Aclar/PVC/aluminijaste folije, deljivi na posamezne odmerke, v škatlah s 84 × 1, 56 × 1 in 28 × 1 trdo kapsulo
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.
Če je potrebno nadaljnje zmanjšanje odmerka, je mogoče odmerek zmanjšati z dveh trdih kapsul dnevno (200 mg) na eno kapsulo dnevno (100 mg).
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).
Podatki o izidih, ki so jih poročale bolnice (PRO - patient-reported outcome), pridobljeni s potrjenimi raziskovalnimi orodji (FOSI in EQ5D), kažejo, da bolnice, zdravljene z niraparibom, niso poročale o razlikah v primerjavi s placebom pri merilih, povezanih s kakovostjo življenja (QoL - quality of life).
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.
Sistemske izpostavljenosti (Cmax in AUC) niraparibu so se pri povečevanju odmerka nirapariba od 30 mg do 400 mg povečevale v sorazmerju z odmerkom.
• If platelet count is < 75,000/μL at any time, resume at a reduced dose.
Če je število trombocitov kadar koli < 75.000/μl, ponovno začnite zdravljenje z zmanjšanim odmerkom.
• Swelling in the feet, ankles, legs, and/or hands
• otekanje stopal, gležnjev, nog in/ali dlani,
M1 is not a CYP1A2 inducer.
M1 ni induktorCYP1A2.
Patients could not have received prior PARP inhibitor therapy, including Zejula.
Bolnice niso smele prejeti predhodnega zdravljenja z zaviralci PARP, vključno z zdravilom Zejula.
The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg.
Odmerek so tri 100 mg trde kapsule enkrat dnevno, kar ustreza skupnemu dnevnemu odmerku 300 mg.
Carcinogenicity studies have not been conducted with niraparib.
Študije karcinogenosti z niraparibom niso bile izvedene.
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.
Hematološki neželeni učinki (trombocitopenija, anemija, nevtropenija), vključno s kliničnimi diagnozami in/ali laboratorijskimi izvidi, so se na splošno pojavljali zgodaj med zdravljenjem s niraparibom, njihova pojavnost pa je s časom upadala.
Niraparib is not a substrate of bile salt export pump (BSEP).
Niraparib ni substrat eksportne črpalke žolčnih soli (BSEP, bile salt export pump).
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.
Če dojite, morate prenehati z dojenjem, preden začnete jemati zdravilo Zejula, in ne smete ponovno dojiti, dokler ne preteče 1 mesec od tega, ko ste vzeli svoj zadnji odmerek.
Animal reproductive and developmental toxicity studies have not been conducted.
Študije vpliva na sposobnost razmnoževanja in razvoj na živalih niso bile izvedene.
Zejula hard capsules contain lactose monohydrate.
Laktoza Trde kapsule zdravila Zejula vsebujejo laktozo monohidrat.
The capsules contain a white to off-white powder.
Kapsule vsebujejo bel do umazano bel prašek.
In repeat-dose oral toxicity studies, niraparib was administered daily for up to 3 months' duration in rats and dogs.
V študijah peroralne toksičnosti pri ponovljenih odmerkih so niraparib do 3 mesece vsak dan dajali podganam in psom.
Capsule shell Titanium dioxide (E 171) Gelatin
Ovojnica kapsule titanov dioksid (E 171)
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.
V analizi populacijske farmakokinetike podatkov iz kliničnih študij pri bolnicah predhodno obstoječa blaga (CLCr < 90 - ≥ 60 ml/min) in zmerna (CLCr < 60 - ≥ 30 ml/min) okvara ledvic ni vplivala na očistek nirapariba.
(20.3-NR)
(20,3-ND)
If adverse reactions are not manageable with this strategy of dose interruption and reduction, it is recommended that Zejula be discontinued.
Če neželenih učinkov ni mogoče obvladati z opisano strategijo prekinitev odmerjanja in zmanjševanja odmerka, je priporočljivo zdravljenje z zdravilom Zejula ukiniti.
Table 4 shows the results for the PFS primary endpoint for the primary efficacy populations (gBRCAmut cohort and the overall non-gBRCAmut cohort).
V preglednici 4 so prikazani rezultati za primarni opazovani dogodek PFS pri populacijah za oceno primarne učinkovitosti (kohorta gBRCAmut in celotna kohorta ne-gBRCAmut).
Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased
Pogosti zvišana gama-glutamil transferaza, zvišana AST, zvišan kreatinin v krvi, zvišana ALT, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
• The active substance is niraparib.
• Učinkovina je niraparib.
A pregnancy test should be performed on all women of childbearing potential prior to treatment.
Pred zdravljenjem je treba pri vseh ženskah v rodni dobi narediti test nosečnosti.
It is therefore recommended to monitor complete blood counts (CBCs) weekly during the first month of treatment and modify the dose as needed.
Zato je priporočljivo, da prvi mesec zdravljenja vsak teden spremljate celotno krvno sliko (CKS) in po potrebi prilagodite odmerek.
Paediatric population No studies have been conducted in paediatric patients.
Pediatrična populacija Študij pri pediatričnih bolnicah niso izvedli.
The pharmacokinetics of niraparib have not been assessed in patients with severe hepatic impairment (see section 4.2).
Farmakokinetike nirapariba niso ocenili pri bolnicah s hudo okvaro jeter (glejte poglavje 4.2).
In the case that the adverse reaction recurs, it is recommended to reduce the dose.
Če se neželeni učinek ponovi, je odmerek priporočljivo zmanjšati.
Niraparib is metabolised primarily by carboxylesterases (CEs) to form a major inactive metabolite, M1.
Niraparib primarno presnavljajo karboksilesteraze (CE), pri čemer nastaja glavni neaktivni presnovek, M1.