FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypertension, including hypertensive crisis, has been reported with the use of Zejula.
Danish: Hypertension, herunder hypertensiv krise, er indberettet ved brug af Zejula.
English: 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 %).
Danish: I det internationale fase 3 pivotale studie (ENGOT-OV16) var der næsten samme forekomst af myelodysplastisk syndrom/akut myeloid leukæmi hos patienter, der fik niraparib (1,4 %), som hos patienter, der fik placebo (1,1 %).
English: The major primary metabolite M1 is not a substrate of P-gp, BCRP, or BSEP.
Danish: Den vigtigste primære metabolit, M1, er ikke et substrat for P-gp, BCRP eller BSEP.
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).
Danish: Demografi, sygdomskarakteristika ved baseline og tidligere behandlingsanamnese var generelt velafbalanceret mellem niraparib- og placeboarmene i kohorterne gBRCAmut (n = 203) og ikke-gBRCAmut (n = 350).
English: Zejula hard capsules have a white opaque body and a purple opaque cap.
Danish: Zejula hårde kapsler har en hvid uigennemsigtig underdel og en lilla uigennemsigtig overdel.
English: The safety and efficacy of niraparib as maintenance therapy was studied in a Phase 3 randomised, double-blind, placebo-controlled international trial (ENGOT-OV16 / NOVA) in patients with relapsed predominantly high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by complete response (CR) or partial response (PR) for more than six months to their penultimate (next to last) platinum-based therapy.
Danish: 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.
English: If you are breast-feeding, you must stop before you start taking Zejula and you must not begin breast-feeding again until 1 month after taking your last dose.
Danish: 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.
English: • Resume Zejula at a reduced dose (100 mg/day).
Danish: • Genoptag Zejula i nedsat dosis (100 mg/dag).
English: In the population pharmacokinetic analysis of data from clinical studies in patients, pre-existing mild (CLCr < 90 - ≥ 60 ml/min) and moderate (CLCr < 60 - ≥ 30 mL/min) renal impairment did not influence the clearance of niraparib.
Danish: 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.
English: • Inflammation of the mouth and/or digestive tract
Danish: • Betændelse i munden og/eller fordøjelseskanalen
English: Also contains lactose and tartrazine (E 102).
Danish: Indeholder også lactose og tartrazin (E 102).
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).
Danish: På grund af risikoen for trombocytopeni skal antikoagulantia og lægemidler, der nedsætter trombocyttallet, anvendes med forsigtighed (se pkt.
English: • Feelings of sadness, depressed
Danish: • Følelse af tristhed, depression
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.
Danish: 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.
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.
Danish: 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.
English: Discontinuation due to anaemia occurred in 1 % of patients.
Danish: Afbrydelse på grund af anæmi skete hos 1 % af patienterne.
English: Zejula 100 mg hard capsules
Danish: Zejula 100 mg, hårde kapsler
English: The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg.
Danish: Dosis er 3 hårde kapsler a 100 mg 1 gang dagligt, svarende til en daglig dosis på i alt 300 mg.
English: Figure 1: Kaplan-Meier plot for progression-free survival in the gBRCAmut cohort based on IRC assessment (ITT population, N = 203)
Danish: Figur 1: Kaplan-Meier-kurve for progressionsfri overlevelse i gBRCAmut-kohorten baseret på IRC-vurdering (ITT-population, N = 203)
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 %)].
Danish: 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 %)].
English: • Resume Zejula at a reduced dose (200 mg/day).
Danish: • Genoptag Zejula ved nedsat dosis (200 mg/dag).
English: If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued.
Danish: Hvis en patient udvikler svær vedvarende hæmatologisk toksicitet, herunder pancytopeni, der ikke forsvinder i løbet af 28 dages afbrydelse, skal Zejula seponeres.
English: Chemotherapy-free interval Median (95 % CI) - mo
Danish: Kemoterapifrit interval Median (95 %-KI) - mo
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.
Danish: 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.
English: • The active substance is niraparib.
Danish: • Aktivt stof: niraparib.
English: Median (95 % CI) - mo
Danish: Median (95 %-KI) - mo
English: • Withhold Zejula for a maximum of 28 days or until resolution of adverse reaction.
Danish: • Tilbagehold Zejula i maksimalt 28 dage eller indtil bedring af bivirkning.
English: If you take more than your normal dose, contact your doctor immediately.
Danish: Kontakt straks lægen, hvis du tager mere end din normale dosis.
English: Following an oral administration of a single 300-mg dose of [14C]-niraparib, on average 86.2 % (range 71 % to 91 %) of the dose was recovered in urine and feces over 21 days.
Danish: 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.
English: It is therefore recommended to monitor complete blood counts (CBCs) weekly during the first month of treatment and modify the dose as needed.
Danish: Det komplette blodtal bør derfor overvåges ugentligt i behandlingens første måned, og dosis skal justeres efter behov.
English: Figure 2: Kaplan-Meier plot for progression-free survival in the non-gBRCAmut cohort overall based on IRC assessment (ITT population, N = 350)
Danish: Figur 2: Kaplan-Meier-kurve for progressionsfri overlevelse i ikke-gBRCAmut-kohorten overordnet set baseret på IRC-vurdering (ITT-population, N = 350)
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.
Danish: 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.
English: In vitro, niraparib weakly inhibits the organic cation transporter 1 (OCT1) with an IC50 = 34.4 µM.
Danish: In vitro er niraparib en svag hæmmer af organisk kationtransportør 1 (OCT1) med en IC50 på 34,4 µm.
English: A sensitivity analysis of investigator PFS showed the following results for the gBRCAmut cohort: HR 0.27 (95 % CI*, 0.182, 0.401; p < 0.0001); median PFS 14.8 months (95% CI*, 12.0, 16.6) for niraparib and median PFS 5.5 months (95% CI*, 4.9, 7.2) for placebo, and for the non-gBRCAmut cohort: HR 0.53 (95 % CI*, 0.405, 0.683; p < 0.0001); median PFS 8.7 months (95 % CI*, 7.3, 10.0) for niraparib and median PFS 4.3 months (95% CI*, 3.7, 5.5) for placebo.
Danish: 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.
English: Anxiety, depression
Danish: Angst, depression
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.
Danish: 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.
English: Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.
Danish: Hver hård kapsel indeholder niraparibtosylatmonohydrat svarende til 100 mg niraparib.
English: Zejula 100 mg hard capsules niraparib
Danish: Zejula 100 mg, hårde kapsler niraparib
English: Estimated Survival Function
Danish: Nedsat leverfunktion
English: Myelodysplastic syndrome/acute myeloid leukaemia
Danish: Myelodysplastisk syndrom/akut myeloid leukæmi
English: Shellac (E 904) Propylene glycol (E 1520) Potassium hydroxide (E 525) Black iron oxide (E 172) Sodium hydroxide (E 524) Povidone (E 1201)
Danish: Shellac (E 904) Propylenglycol (E 1520) Kaliumhydroxid (E 525) Sort jernoxid (E 172) Natriumhydroxid (E 524) Povidon (E 1201)
English: • If platelet count is < 75,000/μL at any time, resume at a reduced dose.
Danish: Hvis trombocyttallet på noget tidspunkt er < 75.000/μl,
English: The recommended dose reductions are first from three hard capsules daily (300 mg) to two hard capsules daily (200 mg).
Danish: De anbefalede dosisnedsættelser er først fra 3 hårde kapsler dagligt (300 mg) til 2 hårde kapsler dagligt (200 mg).
English: • Abnormal taste in mouth
Danish: • Unormal smag i munden
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).
Danish: 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).
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).
Danish: • 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).
English: Approximately 50 % of patients experienced anaemia of any grade, and 25 % experienced Grade 3/4 anaemia.
Danish: Ca. 50 % af patienterne oplevede anæmi af alle grader, og 25 % oplevede anæmi af grad 3/4.
English: The major primary metabolite M1 does not appear to be an inhibitor of P-gp, BCRP, BSEP, or MATE1/2.
Danish: Den vigtigste primære metabolit, M1, synes ikke at være en hæmmer af P-gp, BCRP, BSEP eller MATE1/2.
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).
Danish: 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).
English: Gamma-glutamyl transferase increased, AST increased, blood creatinine increased, ALT increased, blood alkaline phosphatase increased, weight decreased
Danish: Forhøjet gammaglutamyltransferase, forhøjet ASAT, forhøjet kreatinin i blodet, forhøjet ALAT, forhøjet alkalisk fosfatase i blodet, vægttab
English: If you are a woman who could become pregnant you must use reliable contraception while you are taking Zejula, and you must continue to use reliable contraception for 1 month after taking your last dose.
Danish: 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.
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).
Danish: 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).
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).
Danish: I gBRCAmut-kohorten var det mediane antal behandlingscyklusser højere i niraparib-armen end i placeboarmen (hhv. 14 og 7 cyklusser).
English: Some of the patients had a history of bone marrow dysplasia.
Danish: Nogle af patienterne havde også knoglemarvsdysplasi i anamnesen.
English: In vitro, niraparib inhibits P-gp very weakly and BCRP with an IC50 = 161 µM and 5.8 µM, respectively.
Danish: In vitro hæmmer niraparib P-gp meget svagt og BCRP med en IC50 på hhv. 161 µm og 5,8 µm.
English: The median time to onset of thrombocytopenia regardless of grade and Grade 3/4 thrombocytopenia was 22 and 23 days, respectively.
Danish: Den mediane tid til starten af trombocytopeni, uanset grad, og trombocytopeni af grad 3/4, var hhv. 22 og 23 dage.
English: Inhibition of efflux transporters (P-gp, BCRP, BSEP, and MATE1/2) Niraparib is not an inhibitor of BSEP.
Danish: Hæmning af effluxtransportører (P-gp, BCRP, BSEP og MATE1/2) Niraparib er ikke en BSEP-hæmmer.
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).
Danish: I ikke-gBRCAmut-kohorten overordnet set var det mediane antal behandlingscyklusser højere i niraparib-armen end i placeboarmen (hhv. 8 og 5 cyklusser).
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 %.
Danish: Efter intensiv dosisjustering i løbet af de første to måneder af behandling fra 4. cyklus var hyppigheden af nye forekomster af trombocytopeni 1,2 %.
English: Niraparib is eliminated primarily through the hepatobiliary and renal routes.
Danish: Niraparib elimineres primært via leveren/galdevejene og nyrerne.
English: Breast-feeding is contraindicated during administration of Zejula and for 1 month after receiving the last dose (see section 4.3).
Danish: Amning er kontraindiceret under administration af Zejula og i 1 måned efter den sidste dosis (se pkt.
English: If a patient develops severe persistent haematologic toxicity that does not resolve within 28 days following interruption, Zejula should be discontinued.
Danish: Hvis en patient udvikler svær vedvarende hæmatologisk toksicitet, der ikke forsvinder i løbet af 28 dages afbrydelse, skal Zejula seponeres.
English: Second occurrence:
Danish: Anden forekomst:
English: Insomnia, anxiety, depression
Danish: Søvnløshed, angst, depression
English: Niraparib is an inhibitor of MATE1 and -2 with IC50 of 0.18 µM and ≤ 0.14 µM, respectively.
Danish: Niraparib hæmmer MATE1 og -2 med en IC50 på hhv. 0,18 µm og ≤ 0,14 µm.
English: The median duration of thrombocytopenia events of any grade was 23 days, and the median duration of Grade 3/4 thrombocytopenia was 10 days.
Danish: 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.
English: In the HRDneg group, the hazard ratio was 0.58 (95 % CI, 0.361, 0.922; p = 0.0226).
Danish: I HRDneg-gruppen var hazard ratio 0,58 (95 %-KI, 0,361-0,922, p < 0,0226).
English: AST increased, ALT increased, blood alkaline phosphatase increased
Danish: Forhøjet ASAT, forhøjet ALAT, forhøjet alkalisk fosfatase
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of niraparib in paediatric patients.
Danish: Pædiatrisk population Der er ikke gennemført studier til undersøgelse af farmakokinetikken af niraparib hos børn.
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).
Danish: Der var flere patienter i niraparib-gruppen end i placebogruppen, der fortsatte behandling i mere end 12 måneder (hhv. 54,4 % og 16,9 %).
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.
Danish: I den farmakokinetiske populationsanalyse af data fra kliniske studier hos patienter havde eksisterende let og moderat nedsat leverfunktion ingen indflydelse på clearance af niraparib.
English: Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Zejula dose (see section 4.2), if necessary.
Danish: Hypertension skal behandles medicinsk med antihypertensiva, og Zejula-dosis skal om nødvendigt justeres (se pkt.
English: Thrombocytopenia occurred more commonly in patients whose baseline platelet count was less than 180 × 109/L.
Danish: Trombocytopeni forekom hyppigere hos patienter med et trombocyttal på under 180 x 109/l ved baseline.
English: Niraparib as a substrate of CYPs (CYP1A2 and CYP3A4) Niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs) in vivo.
Danish: 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.
English: No patients with pre-existing severe renal impairment or end-stage renal disease undergoing hemodialysis were identified in clinical studies (see section 4.2).
Danish: Der blev ikke identificeret patienter med eksisterende svært nedsat nyrefunktion eller terminal nyresygdom i dialyse i de kliniske studier (se pkt.
English: Dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis
Danish: Mundtørhed, udspilet mave, slimhindebetændelse (herunder mucositis), stomatitis
English: The primary tumour site in most patients (> 80 %) within each cohort was the ovary; most patients (> 84 %) had tumours with serous histology.
Danish: Det primære tumorsted hos de fleste patienter (> 80 %) i hver kohorte var ovarierne.
English: Non-haematologic CTCAE* ≥ Grade 3 treatment-related adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment
Danish: CTCAE*-kriterierne), hvor profylakse ikke anses for at være mulig, eller bivirkning varer ved trods behandling.
English: Niraparib was not mutagenic in a bacterial reverse mutation assay (Ames) test but was clastogenic in an in vitro mammalian chromosomal aberration assay and in an in vivo rat bone marrow micronucleus assay.
Danish: 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.
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.
Danish: Den hvide uigennemsigtige underdel er påtrykt "100 mg" med sort blæk, og den lilla overdel er påtrykt "Niraparib" med hvidt blæk.
English: No dose adjustment is necessary for patients with mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: In the HRDpos group, the hazard ratio was 0.38 (95 % CI, 0.243, 0.586; p < 0.0001).
Danish: I HRDpos-gruppen var hazard ratio 0,38 (95 %-KI, 0,243-0,586, p < 0,0001).
English: • Abnormal blood tests
Danish: • Unormale blodværdier
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).
Danish: 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).
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).
Danish: 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.
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).
Danish: 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).
English: Hypokalemia
Danish: Hypokaliæmi