natgillin/translations-raw huggingface dataset:
Niraparibs sikkerhed og virkning som vedligeholdelsesbehandling blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret internationalt fase 3-studie (ENGOT-OV16/NOVA) hos patienter med recidiv af fortrinsvis høj-grads serøs epitelial ovariecancer, tubacancer eller primær peritonealcancer, som var platinfølsom, defineret ved komplet respons (CR) eller delvis respons (PR) i mere end seks måneder på deres næstsidste platinbaserede terapi. 
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.
Hvis du ammer, skal du holde op, før du begynder at tage Zejula, og du må først begynde at amme igen 1 måned efter, at du har taget din sidste dosis. 
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.
• Genoptag Zejula i nedsat dosis (100 mg/dag). 
• Resume Zejula at a reduced dose (100 mg/day).
I den farmakokinetiske populationsanalyse af data fra kliniske studier hos patienter havde eksisterende let nedsat nyrefunktion (ClCr < 90 - ≥ 60 ml/min) og moderat nedsat nyrefunktion (ClCr < 60 - ≥ 30 ml/min) ingen indflydelse på clearance af niraparib. 
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.
• Betændelse i munden og/eller fordøjelseskanalen 
• Inflammation of the mouth and/or digestive tract
Indeholder også lactose og tartrazin (E 102). 
Also contains lactose and tartrazine (E 102).
På grund af risikoen for trombocytopeni skal antikoagulantia og lægemidler, der nedsætter trombocyttallet, anvendes med forsigtighed (se pkt. 
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).
• Følelse af tristhed, depression 
• Feelings of sadness, depressed
Hæmning af CYP'er (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4) Hverken niraparib eller M1 hæmmer nogen aktivt stof-metaboliserende CYP-enzymer, dvs. CYP1A1/2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4/5. 
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.
Ved ortotopiske xenografttumorer fra patienter med høj-grads serøs ovariecancer (PDX), der er dyrket i mus, er det påvist, at niraparib reducerer tumorvæksten i BRCA 1 og 2-mutant, BRCA-vildtype, men med HR-defekt (homolog rekombination-defekt), og i tumorer af BRCA-vildtype og uden detekterbar HR-defekt. 
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.
Afbrydelse på grund af anæmi skete hos 1 % af patienterne. 
Discontinuation due to anaemia occurred in 1 % of patients.
Zejula 100 mg, hårde kapsler 
Zejula 100 mg hard capsules
Dosis er 3 hårde kapsler a 100 mg 1 gang dagligt, svarende til en daglig dosis på i alt 300 mg. 
The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg.
Figur 1: Kaplan-Meier-kurve for progressionsfri overlevelse i gBRCAmut-kohorten baseret på IRC-vurdering (ITT-population, N = 203) 
Figure 1: Kaplan-Meier plot for progression-free survival in the gBRCAmut cohort based on IRC assessment (ITT population, N = 203)
Efter administration af en enkelt dosis på 300 mg niraparib under faste kunne niraparib måles i plasma i løbet af 30 minutter, og den gennemsnitlige maksimale plasmakoncentration (Cmax) af niraparib blev nået på ca. 3 timer [804 ng/ml (% CV:50,2 %)]. 
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 %)].
• Genoptag Zejula ved nedsat dosis (200 mg/dag). 
• Resume Zejula at a reduced dose (200 mg/day).
Hvis en patient udvikler svær vedvarende hæmatologisk toksicitet, herunder pancytopeni, der ikke forsvinder i løbet af 28 dages afbrydelse, skal Zejula seponeres. 
If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued.
Kemoterapifrit interval Median (95 %-KI) - mo 
Chemotherapy-free interval Median (95 % CI) - mo
I NOVA-studiet havde patienter, som var egnede til Zejula-behandling, følgende hæmatologiske værdier ved baseline: absolut neutrofilttal (ANC) ≥ 1.500 celler/µl, trombocyttal ≥ 100.000 celler/µl og hæmoglobin ≥ 9 g/dl før behandling. 
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.
• Aktivt stof: niraparib. 
• The active substance is niraparib.
Median (95 %-KI) - mo 
Median (95 % CI) - mo
• Tilbagehold Zejula i maksimalt 28 dage eller indtil bedring af bivirkning. 
• Withhold Zejula for a maximum of 28 days or until resolution of adverse reaction.
Kontakt straks lægen, hvis du tager mere end din normale dosis. 
If you take more than your normal dose, contact your doctor immediately.
Efter oral administration af en enkelt dosis [14C]-niraparib på 300 mg blev i gennemsnit 86,2 % (interval 71-91 %) af dosis udskilt i urinen og fæces i løbet af 21 dage. 
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.
Det komplette blodtal bør derfor overvåges ugentligt i behandlingens første måned, og dosis skal justeres efter behov. 
It is therefore recommended to monitor complete blood counts (CBCs) weekly during the first month of treatment and modify the dose as needed.
Figur 2: Kaplan-Meier-kurve for progressionsfri overlevelse i ikke-gBRCAmut-kohorten overordnet set baseret på IRC-vurdering (ITT-population, N = 350) 
Figure 2: Kaplan-Meier plot for progression-free survival in the non-gBRCAmut cohort overall based on IRC assessment (ITT population, N = 350)
Hård kapsel på ca. 22 × 8 mm, hvid underdel med "100 mg" trykt med sort blæk og lilla overdel med "Niraparib" trykt med hvidt blæk. 
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.
In vitro er niraparib en svag hæmmer af organisk kationtransportør 1 (OCT1) med en IC50 på 34,4 µm. 
In vitro, niraparib weakly inhibits the organic cation transporter 1 (OCT1) with an IC50 = 34.4 µM.
En følsomhedsanalyse af investigator-PFS viste følgende resultater for gBRCA-mut-kohorten: HR 0,27 (95 %-KI*, 0,182-0,401; p < 0,0001); median PFS 14,8 måneder (95 %-KI*, 12,0-16,6) for niraparib og median PFS 5,5 måneder (95 %-KI*, 4,9-7,2) for placebo, og for ikke-gBRCA-mutkohorten: HR 0,53 (95 %-KI*, 0,405-0,683; p < 0,0001); median PFS 8,7 måneder (95 %-KI*, 7,3-10,0) for niraparib og median PFS 4,3 måneder (95 %-KI*, 3,7-5,5) for placebo. 
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.
Angst, depression 
Anxiety, depression
Zejula er indiceret som monoterapi til vedligeholdelsesbehandling af voksne patienter med recidiv af platinfølsom høj-grads serøs epitelial ovariecancer, tubacancer eller primær peritonealcancer, som udviser (fuldstændig eller delvis) respons på platinbaseret kemoterapi. 
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.
Hver hård kapsel indeholder niraparibtosylatmonohydrat svarende til 100 mg niraparib. 
Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.
Zejula 100 mg, hårde kapsler niraparib 
Zejula 100 mg hard capsules niraparib
Nedsat leverfunktion 
Estimated Survival Function
Myelodysplastisk syndrom/akut myeloid leukæmi 
Myelodysplastic syndrome/acute myeloid leukaemia
Shellac (E 904) Propylenglycol (E 1520) Kaliumhydroxid (E 525) Sort jernoxid (E 172) Natriumhydroxid (E 524) Povidon (E 1201) 
Shellac (E 904) Propylene glycol (E 1520) Potassium hydroxide (E 525) Black iron oxide (E 172) Sodium hydroxide (E 524) Povidone (E 1201)
Hvis trombocyttallet på noget tidspunkt er < 75.000/μl, 
• If platelet count is < 75,000/μL at any time, resume at a reduced dose.
De anbefalede dosisnedsættelser er først fra 3 hårde kapsler dagligt (300 mg) til 2 hårde kapsler dagligt (200 mg). 
The recommended dose reductions are first from three hard capsules daily (300 mg) to two hard capsules daily (200 mg).
• Unormal smag i munden 
• Abnormal taste in mouth
Studiet opfyldte sit primære formål med statistisk signifikant forbedret PFS ved vedligeholdelsesmonoterapi med niraparib sammenlignet med placebo i gBRCAmut-kohorten (HR 0,27, 95 %-KI* 0,173-0,410, p < 0,0001) samt i ikke-gBRCAmut-kohorten overordnet set (HR 0,45, 95 %-KI* 0,338-0,607, p < 0,0001). 
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).
• Øvrige indholdsstoffer: kapslens indhold: magnesiumstearat, lactosemonohydrat kapslens skal: titandioxid (E 171), gelatine, brilliant blue FCF (E 133), erythrosin (E 127), tartrazin (E 102) trykfarve: shellac (E 904), propylenglycol (E 1520), kaliumhydroxid (E 525), sort jernoxid (E 172), natriumhydroxid (E 524) og povidon (E 1201). 
• 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).
Ca. 50 % af patienterne oplevede anæmi af alle grader, og 25 % oplevede anæmi af grad 3/4. 
Approximately 50 % of patients experienced anaemia of any grade, and 25 % experienced Grade 3/4 anaemia.
Den vigtigste primære metabolit, M1, synes ikke at være en hæmmer af P-gp, BCRP, BSEP eller MATE1/2. 
The major primary metabolite M1 does not appear to be an inhibitor of P-gp, BCRP, BSEP, or MATE1/2.
Niraparib som substrat for effluxtransportører (P-gp, BCRP og MATE1/2) Niraparib er et substrat for P-glycoprotein (P-gp) og Breast Cancer Resistance Protein (BCRP). 
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).
Forhøjet gammaglutamyltransferase, forhøjet ASAT, forhøjet kreatinin i blodet, forhøjet ALAT, forhøjet alkalisk fosfatase i blodet, vægttab 
Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased
Hvis du er en kvinde, der kan blive gravid, skal du bruge sikker prævention, mens du tager Zejula, og du skal blive ved med at bruge sikker prævention i 1 måned, efter at du har taget den sidste dosis. 
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.
Zejula anvendes til voksne kvinder til behandling af kræft i æggestokkene, æggelederne (den del af kvindens kønsorganer, der forbinder æggestokkene med livmoderen) eller bughinden (den hinde, der beklæder bugvæggens inderside). 
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).
I gBRCAmut-kohorten var det mediane antal behandlingscyklusser højere i niraparib-armen end i placeboarmen (hhv. 14 og 7 cyklusser). 
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).
Nogle af patienterne havde også knoglemarvsdysplasi i anamnesen. 
Some of the patients had a history of bone marrow dysplasia.
In vitro hæmmer niraparib P-gp meget svagt og BCRP med en IC50 på hhv. 161 µm og 5,8 µm. 
In vitro, niraparib inhibits P-gp very weakly and BCRP with an IC50 = 161 µM and 5.8 µM, respectively.
Den mediane tid til starten af trombocytopeni, uanset grad, og trombocytopeni af grad 3/4, var hhv. 22 og 23 dage. 
The median time to onset of thrombocytopenia regardless of grade and Grade 3/4 thrombocytopenia was 22 and 23 days, respectively.
Hæmning af effluxtransportører (P-gp, BCRP, BSEP og MATE1/2) Niraparib er ikke en BSEP-hæmmer. 
Inhibition of efflux transporters (P-gp, BCRP, BSEP, and MATE1/2) Niraparib is not an inhibitor of BSEP.
I ikke-gBRCAmut-kohorten overordnet set var det mediane antal behandlingscyklusser højere i niraparib-armen end i placeboarmen (hhv. 8 og 5 cyklusser). 
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).
Efter intensiv dosisjustering i løbet af de første to måneder af behandling fra 4. cyklus var hyppigheden af nye forekomster af trombocytopeni 1,2 %. 
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 %.
Niraparib elimineres primært via leveren/galdevejene og nyrerne. 
Niraparib is eliminated primarily through the hepatobiliary and renal routes.
Amning er kontraindiceret under administration af Zejula og i 1 måned efter den sidste dosis (se pkt. 
Breast-feeding is contraindicated during administration of Zejula and for 1 month after receiving the last dose (see section 4.3).
Hvis en patient udvikler svær vedvarende hæmatologisk toksicitet, der ikke forsvinder i løbet af 28 dages afbrydelse, skal Zejula seponeres. 
If a patient develops severe persistent haematologic toxicity that does not resolve within 28 days following interruption, Zejula should be discontinued.
Anden forekomst: 
Second occurrence:
Søvnløshed, angst, depression 
Insomnia, anxiety, depression
Niraparib hæmmer MATE1 og -2 med en IC50 på hhv. 0,18 µm og ≤ 0,14 µm. 
Niraparib is an inhibitor of MATE1 and -2 with IC50 of 0.18 µM and ≤ 0.14 µM, respectively.
Den mediane varighed af trombocytopeni-hændelser af alle grader var 23 dage, og den mediane varighed af trombocytopeni-hændelser af grad 3/4 var 10 dage. 
The median duration of thrombocytopenia events of any grade was 23 days, and the median duration of Grade 3/4 thrombocytopenia was 10 days.
I HRDneg-gruppen var hazard ratio 0,58 (95 %-KI, 0,361-0,922, p < 0,0226). 
In the HRDneg group, the hazard ratio was 0.58 (95 % CI, 0.361, 0.922; p = 0.0226).
Forhøjet ASAT, forhøjet ALAT, forhøjet alkalisk fosfatase 
AST increased, ALT increased, blood alkaline phosphatase increased
Pædiatrisk population Der er ikke gennemført studier til undersøgelse af farmakokinetikken af niraparib hos børn. 
Paediatric population No studies have been conducted to investigate the pharmacokinetics of niraparib in paediatric patients.
Der var flere patienter i niraparib-gruppen end i placebogruppen, der fortsatte behandling i mere end 12 måneder (hhv. 54,4 % og 16,9 %). 
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).
I den farmakokinetiske populationsanalyse af data fra kliniske studier hos patienter havde eksisterende let og moderat nedsat leverfunktion ingen indflydelse på clearance af niraparib. 
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.
Hypertension skal behandles medicinsk med antihypertensiva, og Zejula-dosis skal om nødvendigt justeres (se pkt. 
Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Zejula dose (see section 4.2), if necessary.
Trombocytopeni forekom hyppigere hos patienter med et trombocyttal på under 180 x 109/l ved baseline. 
Thrombocytopenia occurred more commonly in patients whose baseline platelet count was less than 180 × 109/L.
Niraparib er et substrat for CYP'er (CYP1A2 og CYP3A4) Niraparib er et substrat for carboxylesteraser (CE'er) og UDP-glucuronosyltransferaser (UGT'er) in vivo. 
Niraparib as a substrate of CYPs (CYP1A2 and CYP3A4) Niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs) in vivo.
Der blev ikke identificeret patienter med eksisterende svært nedsat nyrefunktion eller terminal nyresygdom i dialyse i de kliniske studier (se pkt. 
No patients with pre-existing severe renal impairment or end-stage renal disease undergoing hemodialysis were identified in clinical studies (see section 4.2).
Mundtørhed, udspilet mave, slimhindebetændelse (herunder mucositis), stomatitis 
Dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis
Det primære tumorsted hos de fleste patienter (> 80 %) i hver kohorte var ovarierne. 
The primary tumour site in most patients (> 80 %) within each cohort was the ovary; most patients (> 84 %) had tumours with serous histology.
CTCAE*-kriterierne), hvor profylakse ikke anses for at være mulig, eller bivirkning varer ved trods behandling. 
Non-haematologic CTCAE* ≥ Grade 3 treatment-related adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment
Niraparib var ikke mutagent i en bakteriel revers mutationsanalyse (Ames), men var klastogent i en in vitro-kromosomafvigelsesanalyse hos pattedyr og i en in vivo-analyse af knoglemarvsmikronukleus hos rotter. 
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.
Den hvide uigennemsigtige underdel er påtrykt "100 mg" med sort blæk, og den lilla overdel er påtrykt "Niraparib" med hvidt blæk. 
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.
Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion. 
No dose adjustment is necessary for patients with mild to moderate renal impairment.
I HRDpos-gruppen var hazard ratio 0,38 (95 %-KI, 0,243-0,586, p < 0,0001). 
In the HRDpos group, the hazard ratio was 0.38 (95 % CI, 0.243, 0.586; p < 0.0001).
• Unormale blodværdier 
• Abnormal blood tests
Derfor bør der udvises forsigtighed, når niraparib kombineres med aktive stoffer, hvis metabolisering er CYP3A4-afhængig, og især stoffer, som har et smalt terapeutisk indeks (f.eks. ciclosporin, tacrolimus, alfentanil, ergotamin, pimozid, quetiapin og halofantrin). 
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).
Zejula må ikke bruges under graviditet eller til kvinder i den fødedygtige alder, som ikke vil anvende sikker prævention under behandlingen og i 1 måned efter den sidste dosis Zejula (se pkt. 
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).
Derfor bør der udvises forsigtighed, når niraparib kombineres med aktive stoffer, hvis metabolisering er CYP1A2-afhængig, og navnlig stoffer, som har et smalt terapeutisk indeks (f.eks. clozapin, theophyllin og ropinirol). 
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).
Hypokaliæmi 
Hypokalemia
Hos patienter med et trombocyttal ved baseline på mindre end 180 × 109/l sås trombocytopeni af alle grader hos 76 % af patienterne og af grad 3/4 hos 45 % af patienterne. 
In patients with baseline platelet count less than 180 × 109/L, thrombocytopenia of any grade and Grade 3/4 occurred in 76 % and 45 % of the patients, respectively.
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 254,5 mg lactosemonohydrat (se pkt. 
Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4).
Ca. 30 % af de patienter, som fik Zejula, oplevede neutropeni af alle grader, og 20 % af patienterne oplevede neutropeni af grad 3/4. 
Approximately 30 % of patients receiving Zejula experienced neutropenia of any grade, and 20 % of patients experienced Grade 3/4 neutropenia.
Efter en enkelt oral dosis niraparib på 300 mg lå niraparibs gennemsnitlige terminale halveringstid (t½) på 48-51 timer (ca. 2 dage). 
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).
Kvinder i den fødedygtige alder skal anvende sikker prævention under behandlingen og i 1 måned efter den sidste dosis Zejula. 
Women of childbearing potential must use effective contraception during therapy and for 1 month after receiving the last dose of Zejula.
I det kliniske program blev neutropeni håndteret ved hjælp af laboratorieovervågning og dosisjusteringer (se pkt. 
In the clinical programme, neutropenia was managed with laboratory monitoring and dose modifications (see section 4.2).
Ca. 76 % af patienterne med en lav blodpladeværdi ved baseline (< 180 × 109/l), som fik Zejula, oplevede trombocytopeni (alle grader), og 45 % af patienterne oplevede trombocytopeni af grad 3-4. 
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.
Trombocytopeni, anæmi, neutropeni 
Thrombocytopenia, anaemia, neutropenia
Genoptag Zejula i nedsat dosis. 
• Resume Zejula at a reduced dose.
Tilbagehold Zejula i maksimalt 28 dage, og overvåg blodtallene ugentligt, indtil neutrofiltallet igen er ≥ 1.500/µl, eller hæmoglobin igen er ≥ 9 g/dl. 
• 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.
Brug ikke dette lægemiddel, hvis emballagen er beskadiget eller brudt. 
Do not use this medicine if you notice any damage or signs of tampering to the pack.
(Nir:plac) (95 %-KI*) 
(Nir:plac) (95 % CI*) * CI denotes confidence interval.
Hypertension, herunder hypertensiv krise, er indberettet i forbindelse med behandling med Zejula. 
Hypertension, including hypertensive crisis, has been reported with Zejula therapy.