FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased niraparib-induced cytotoxicity was observed in tumour cell lines with or without deficiencies in the BReast CAncer (BRCA) 1 and 2 tumour suppressor genes.
Slovenian: Povečano citotoksičnost, ki jo povzroča niraparib, so opazili v tumorskih celičnih linijah z okvarami tumorskih supresorskih genov raka dojke (BRCA, BReast CAncer) 1 in 2 ali brez njih.
English: PFS median (95% CI*)
Slovenian: mediano PFS (95-% IZ*)
English: Table 1: Dose modifications for non-haematologic adverse reactions
Slovenian: Preglednica 2: Prilagajanje odmerka zaradi hematoloških neželenih učinkov
English: (13.3-NR)
Slovenian: (13,3-ND)
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).
Slovenian: V kohorti gBRCAmut je bilo mediano število ciklov zdravljenja višje v kraku z niraparibom kot v kraku s placebom (14 oziroma 7 ciklov).
English: Zejula lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia).
Slovenian: Zdravilo Zejula zniža števila vaših krvnih celic, kot so število rdečih krvničk (anemija), število belih krvničk (nevtropenija) ali število krvnih ploščic (trombocitopenija).
English: Pre-existing hypertension should be adequately controlled before starting Zejula treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom Zejula je treba ustrezno obvladati obstoječo hipertenzijo.
English: The recommended dose reductions are first from three hard capsules daily (300 mg) to two hard capsules daily (200 mg).
Slovenian: Priporočeno zmanjšanje odmerka je naprej s treh trdih kapsul dnevno (300 mg) na dve trdi kapsuli dnevno (200 mg).
English: The primary tumour site in most patients (> 80 %) within each cohort was the ovary; most patients (> 84 %) had tumours with serous histology.
Slovenian: Primarno mesto tumorja pri večini bolnic (> 80 %) v vsaki kohorti je bil jajčnik.
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.
Slovenian: Niraparib v preskusu bakterijske reverzne mutacije (Ames) ni bil mutagen, vendar pa je bil klastogen v in vitro preskusu kromosomskih aberacij sesalcev ter v in vivo preskusu mikronukleusov v podganjem kostnem mozgu.
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).
Slovenian: Zato je priporočljiva previdnost pri kombiniranju nirapariba z učinkovinami, katerih presnova je odvisna od CYP1A2, zlasti tistimi, ki imajo ozek terapevtski razpon (npr. klozapin, teofilin in ropinirol).
English: CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered Zejula 100 mg/day
Slovenian: CTCAE, ki je prisoten več kot 28 dni, medtem ko bolnica prejema zdravilo Zejula 100 mg/dan
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).
Slovenian: Zato je priporočljiva previdnost pri kombiniranju nirapariba z učinkovinami, katerih presnova je odvisna od CYP3A4, zlasti tistimi, ki imajo ozek terapevtski razpon (npr. ciklosporin, takrolimus, alfentanil, ergotamin, pimozid, kvetiapin in halofantrin).
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).
Slovenian: Več bolnic iz skupine z niraparibom kot bolnic iz skupine s placebom je nadaljevalo zdravljenje več kot 12 mesecev (54,4 % oziroma 16,9 %).
English: How to take Zejula
Slovenian: Kako jemati zdravilo Zejula
English: Shellac (E 904) Propylene glycol (E 1520) Potassium hydroxide (E 525) Black iron oxide (E 172) Sodium hydroxide (E 524) Povidone (E 1201)
Slovenian: Tiskarsko črnilo šelak (E 904) propilenglikol (E 1520) kalijev hidroksid (E 525) črni železov oksid (E 172) natrijev hidroksid (E 524) povidon (E 1201)
English: The following adverse reactions have been identified in the ENGOT-OV16 study in patients receiving Zejula monotherapy (see Table 3).
Slovenian: V študiji ENGOT-OV16 so pri bolnicah, ki so prejemale monoterapijo z zdravilom Zejula, ugotovili naslednje neželene učinke (glejte preglednico 3).
English: Hypertension should be medically managed with antihypertensive medicinal products as well as adjustment of the Zejula dose (see section 4.2), if necessary.
Slovenian: Hipertenzijo je treba medicinsko obvladati z zdravili proti hipertenziji in po potrebi tudi prilagoditvijo odmerka zdravila Zejula (glejte poglavje 4.2).
English: In vitro, niraparib inhibits P-gp very weakly and BCRP with an IC50 = 161 µM and 5.8 µM, respectively.
Slovenian: Niraparib in vitro zavira BCRP in zelo šibko zavira P-gp, z IC50 = 5,8 µM oziroma 161 µM.
English: Following a single oral 300-mg dose of niraparib, the mean terminal half-life (t½) of niraparib ranged from 48 to 51 hours (approximately 2 days).
Slovenian: Po enkratnem peroralnem odmerku 300 mg nirapariba se je povprečni terminalni razpolovni čas (t½) nirapariba gibal od 48 do 51 ur (približno 2 dni).
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).
Slovenian: V celotni kohorti ne-gBRCAmut je bilo mediano število ciklov zdravljenja višje v kraku z niraparibom kot v kraku s placebom (8 oziroma 5 ciklov).
English: • Resume Zejula at a reduced dose (100 mg/day).
Slovenian: • Ponovno začnite zdravljenje z zdravilom Zejula z zmanjšanim odmerkom (100 mg/dan).
English: Within each cohort, patients were randomised using a 2:1 allocation of niraparib and placebo.
Slovenian: V vsaki kohorti so bile bolnice randomizirane v skupino z niraparibom ali placebom v razmerju 2 : 1.
English: In most cases, hypertension was controlled adequately using standard antihypertensive treatment with or without Zejula dose adjustment (see section 4.2).
Slovenian: V večini primerov je bila hipertenzija zadostno obvladana s standardnim zdravljenjem proti hipertenziji ob zmanjšanju odmerka ali brez zmanjšanja odmerka zdravila Zejula (glejte poglavje 4.2).
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.
Slovenian: Na ksenotransplantiranih tumorjih, pridobljenih iz bolnic z ortotopskim seroznim rakom jajčnika visoke stopnje (PDX, patient-derived xenograft tumours), ki so jih gojili na miših, so za niraparib dokazali, da zmanjšuje rast tumorjev pri mutiranem BRCA 1 in 2, BRCA divjega tipa s pomanjkanjem homologne rekombinacije (HR) in pri tumorjih divjega tipa BRCA brez zaznavnega pomanjkanja HR.
English: There are no data in patients with severe hepatic impairment; use with caution in these patients (see section 5.2).
Slovenian: Podatkov za bolnice s hudo okvaro jeter ni; pri teh bolnicah zdravilo uporabljajte previdno (glejte poglavje 5.2).
English: Discontinuation due to anaemia occurred in 1 % of patients.
Slovenian: Do ukinitve zdravljenja zaradi anemije je prišlo pri 1 % bolnic.
English: In the HRDneg group, the hazard ratio was 0.58 (95 % CI, 0.361, 0.922; p = 0.0226).
Slovenian: V skupini, negativni za HRD, je bilo razmerje tveganja 0,58 (95-% IZ, 0,361, 0,922; p = 0,0226).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for niraparib, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za niraparib je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: The major primary metabolite M1 does not appear to be an inhibitor of P-gp, BCRP, BSEP, or MATE1/2.
Slovenian: Za glavni primarni presnovek M1 kaže, da ni zaviralec P-gp, BCRP, BSEP ali MATE 1/2.
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.
Slovenian: Po peroralnem dajanju enkratnega odmerka 300 mg [14C]nirapariba je bilo v 21 dneh iz urina in blata v povprečju pridobljenega 86,2 % (razpon od 71 % do 91 %) odmerka.
English: Anaemia of any grade might persist during Zejula treatment.
Slovenian: Med zdravljenjem z zdravilom Zejula je lahko anemija katere koli stopnje dolgotrajna.
English: Diarrhoea, constipation, mucosal inflammation (including mucositis), stomatitis, dry mouth
Slovenian: Občasni driska, zaprtje, vnetje sluznic (vključno z mukozitisom), stomatitis, suha usta
English: Also contains lactose and tartrazine (E 102).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo in tartrazin (E 102).
English: • Resume Zejula at a reduced dose (200 mg/day).
Slovenian: • Ponovno začnite zdravljenje z zdravilom Zejula z zmanjšanim odmerkom (200 mg/dan).
English: Population pharmacokinetic analyses indicated that age, weight and race had no significant impact on the pharmacokinetics of niraparib.
Slovenian: Starost, telesna masa in rasa Analize populacijske farmakokinetike kažejo, da starost, telesna masa in rasa nimajo znatnega vpliva na farmakokinetiko nirapariba.
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.
Slovenian: Na belem neprosojnem telesu kapsule je s črnim črnilom natisnjen napis »100 mg«, na vijoličastem pokrovčku kapsule pa je z belim črnilom natisnjen napis »Niraparib«.
English: (Nir:plac) (95 % CI*) * CI denotes confidence interval.
Slovenian: (nir : plac) (95-% IZ*)
English: Zejula hard capsules have a white opaque body and a purple opaque cap.
Slovenian: Zdravilo Zejula trde kapsule imajo belo neprosojno telo in vijoličast neprosojen pokrovček.
English: The experimental test was not able to discriminate which patients would or would not benefit from niraparib maintenance therapy.
Slovenian: Eksperimentalni test ni mogel ločevati med bolnicami, ki bodo imele korist od vzdrževalnega zdravljenja z niraparibom, in tistimi, ki je ne bodo imele.
English: However, based on its mechanism of action, niraparib could cause embryonic or foetal harm, including embryo-lethal and teratogenic effects, when administered to a pregnant woman.
Slovenian: Vendar bi lahko niraparib pri dajanju nosečnicam zaradi svojega mehanizma delovanja imel škodljiv učinek na zarodek ali plod, vključno s smrtjo zarodka in teratogenimi učinki.
English: Women of childbearing potential must use effective contraception during therapy and for 1 month after receiving the last dose of Zejula.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in še 1 mesec po prejemu zadnjega odmerka zdravila Zejula uporabljati učinkovito kontracepcijo.
English: AST increased, ALT increased, blood alkaline phosphatase increased
Slovenian: Občasni zvišana AST, zvišana ALT, zvišana alkalna fosfataza v krvi
English: Dose reductions may be implemented based on adverse reactions.
Slovenian: Na osnovi neželenih učinkov je mogoče odmerek zmanjšati.
English: Do not chew or crush the capsules.
Slovenian: Kapsul ne smete žvečiti ali zdrobiti.
English: If a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption, Zejula should be discontinued.
Slovenian: Če se pri bolnici razvije huda dolgotrajna hematološka toksičnost, vključno s pancitopenijo, ki ne izzveni v 28 dneh po prekinitvi zdravljenja, je treba zdravljenje z zdravilom Zejula ukiniti.
English: In the clinical programme, neutropenia was managed with laboratory monitoring and dose modifications (see section 4.2).
Slovenian: kliničnem programu so nevtropenijo obvladovali z laboratorijskim spremljanjem in prilagajanjem odmerka (glejte poglavje 4.2).
English: Approximately 30 % of patients receiving Zejula experienced neutropenia of any grade, and 20 % of patients experienced Grade 3/4 neutropenia.
Slovenian: Pri približno 30 % bolnic, ki so prejemale zdravilo Zejula, se je pojavila nevtropenija katere koli stopnje, pri 20 % bolnic pa se je pojavila nevtropenija 3. ali 4. stopnje.
English: Discontinuation due to hypertension occurred in < 1 % of patients.
Slovenian: Do ukinitve zdravljenja zaradi hipertenzije je prišlo pri < 1 % bolnic.
English: Zejula contains lactose
Slovenian: Zdravilo Zejula vsebuje laktozo
English: What Zejula is used for
Slovenian: Za kaj uporabljamo zdravilo Zejula
English: Myelodysplastic syndrome/acute myeloid leukaemia Rarely, low blood-cell counts may be a sign of more serious problems with the bone marrow such as
Slovenian: Mielodisplastični sindrom (MDS) ali akutna mieloična levkemija V redkih primerih so lahko nizka števila krvnih celic znak resnejših težav s kostnim mozgom, kot sta »mielodisplastični sindrom« (MDS) ali »akutna mieloična levkemija« (AML).
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.
Slovenian: Mediani čas trajanja dogodkov trombocitopenije katere koli stopnje je bil 23 dni in mediani čas trajanja trombocitopenije 3. ali 4. stopnje je bil 10 dni.
English: If a patient develops severe persistent haematologic toxicity that does not resolve within 28 days following interruption, Zejula should be discontinued.
Slovenian: Če se pri bolnici razvije huda dolgotrajna hematološka toksičnost, ki ne izzveni v 28 dneh po prekinitvi zdravljenja, je treba zdravljenje z zdravilom Zejula ukiniti.
English: If you take more than your normal dose, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Zejula, kot bi smeli Takoj obvestite zdravnika, če ste vzeli več kot svoj običajni odmerek zdravila.
English: In the HRDpos group, the hazard ratio was 0.38 (95 % CI, 0.243, 0.586; p < 0.0001).
Slovenian: V skupini, pozitivni za HRD, je bilo razmerje tveganja 0,38 (95-% IZ, 0,243, 0,586; p < 0,0001).
English: Confirmed diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia
Slovenian: Potrjena diagnoza mielodisplastičnega sindroma (MDS) ali akutne mieloične levkemije (AML)
English: • Inflammation of the mouth and/or digestive tract
Slovenian: • vnetje v ustih in/ali prebavilih,
English: Zejula contains the active substance niraparib.
Slovenian: Zdravilo Zejula vsebuje učinkovino niraparib.
English: If adverse reactions persist beyond a 28-day dose interruption, it is recommended that Zejula be discontinued.
Slovenian: Če je neželeni učinek prisoten tudi po 28-dnevni prekinitvi zdravljenja, je priporočljivo zdravljenje z zdravilom Zejula ukiniti.
English: • Pink eye
Slovenian: • rdeče oči (konjuktivitis),
English: In the clinical programme, anaemia was managed with laboratory monitoring, dose modification (see section 4.2), and where appropriate with red blood cell transfusions.
Slovenian: V kliničnem programu so anemijo obvladovali z laboratorijskim spremljanjem, prilagajanjem odmerka (glejte poglavje 4.2) in, kjer je bilo primerno, s transfuzijami eritrocitov.
English: • Decreased appetite
Slovenian: • glavobol, • zmanjšan apetit,
English: Reproductive and developmental toxicity studies have not been conducted with niraparib.
Slovenian: Študije vpliva na sposobnost razmnoževanja in razvoj z niraparibom niso bile izvedene.
English: Dry mouth, abdominal distension, mucosal inflammation (including mucositis), stomatitis
Slovenian: Pogosti suha usta, abdominalna distenzija, vnetje sluznic (vključno z mukozitisom),
English: There are no data in patients with severe renal impairment or end stage renal disease undergoing haemodialysis; use with caution in these patients (see section 5.2).
Slovenian: Podatkov za bolnice s hudo okvaro ledvic ali končno ledvično odpovedjo, ki prejemajo hemodializo, ni; pri teh bolnicah zdravilo uporabljajte previdno (glejte poglavje 5.2).
English: Zejula has moderate influence on the ability to drive or use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Zejula ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: These findings occurred at exposure levels below those seen clinically, and were largely reversible within 4 weeks of cessation of dosing.
Slovenian: Do teh ugotovitev je prišlo pri stopnjah izpostavljenosti, nižjih od stopenj klinične izpostavljenosti.
English: • Shortness of breath
Slovenian: • pomanjkanje sape,
English: Hepatic impairment
Slovenian: Občasni glavobol
English: • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥ 1,500/µL or haemoglobin returns to ≥ 9 g/dL.
Slovenian: 28 dni in tedensko spremljajte število krvnih celic, dokler se število nevtrofilcev ne povrne na ≥ 1.500/µl oziroma se raven hemoglobina ne povrne na ≥ 9 g/dl.
English: The median time to onset of anaemia of any grade was 42 days, and 85 days for Grade 3/4 events.
Slovenian: Mediani čas do nastopa anemije katere koli stopnje je bil 42 dni, do dogodka 3. ali 4. stopnje pa 85 dni.
English: Zejula 100 mg capsules niraparib
Slovenian: IME ZDRAVILA Zejula 100 mg kapsule niraparib
English: Approximately 25 % of patients in the NOVA study weighed less than 58 kg, and approximately 25 % of patients weighed more than 77 kg.
Slovenian: Bolnice z majhno telesno maso Približno 25 % bolnic v študiji NOVA je tehtalo manj kot 58 kg in približno 25 % bolnic je tehtalo več kot 77 kg. Pojavnost neželenih učinkov zdravila stopnje 3 ali 4 je bila višja pri bolnicah z majhno telesno maso (78 %) kot pri bolnicah z veliko telesno maso (53 %).
English: A starting dose of 200 mg for patients weighing less than 58 kg may be considered.
Slovenian: 58 kg, lahko razmislite o začetnem odmerku 200 mg.
English: Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy.
Slovenian: Če nastopi hipertenzivna kriza ali pa medicinsko pomembne hipertenzije ni mogoče zadostno obvladati z zdravljenjem proti hipertenziji, je treba zdravljenje z zdravilom Zejula ukiniti.
English: Dyspnea, cough, nasopharyngitis
Slovenian: Zelo pogosti dispneja, kašelj, nazofaringitis
English: B: Placebo
Slovenian: Placebo
English: Zejula 100 mg hard capsules
Slovenian: IME ZDRAVILA Zejula 100 mg trde kapsule
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.
Slovenian: 0,182, 0,401; p < 0,0001); mediano PFS 14,8 meseca (95-% IZ*, 12,0, 16,6) za niraparib in mediano PFS 5,5 meseca (95-% IZ*, 4,9, 7,2) za placebo; za kohorto ne-gBRCAmut pa naslednje rezultate:
English: The median time to onset of neutropenia of any grade was 27 days, and 29 days for Grade 3/4 events.
Slovenian: Mediani čas do nastopa nevtropenije katere koli stopnje je bil 27 dni, do dogodkov 3. ali 4. stopnje pa 29 dni.
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).
Slovenian: V kliničnih študijah niso zabeležili bolnic s predhodno obstoječo hudo okvaro ledvic ali končno odpovedjo ledvic, ki so prejemale hemodializo (glejte poglavje 4.2).
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OAT1 (e.g. probenecid) or OAT3 (e.g. probenecid, diclofenac), or OCT2 (e.g. cimetidine, quinidine) uptake transporters.
Slovenian: Pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo privzemne prenašalce OAT1 (npr. probenecid) ali OAT3 (npr. probenecid, diklofenak) ali OCT2 (npr. cimetidin, kvinidin), prilagoditev odmerka ni potrebna.
English: Zejula 100 mg hard capsules niraparib
Slovenian: IME ZDRAVILA Zejula 100 mg trde kapsule niraparib
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OATP1B1 or 1B3 (e.g. gemfibrozil, ritonavir), or OCT1 (e.g. dolutegravir) uptake transporters.
Slovenian: Pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo privzemne prenašalce OATP1B1 ali 1B3 (npr. gemfibrozil, ritonavir) ali OCT1 (npr. dolutegravir), prilagoditev odmerka ni potrebna.
English: The median duration of neutropenia of any grade was 26 days, and 13 days for Grade 3/4 events.
Slovenian: Mediani čas trajanja nevtropenije katere koli stopnje je bil 26 dni, dogodkov 3. ali 4. stopnje pa 13 dni.
English: • Permanently discontinue Zejula.
Slovenian: Trajno ukinite zdravljenje z zdravilom Zejula.
English: Approximately 60 % of patients receiving Zejula experienced thrombocytopenia of any grade, and 34 % of patients experienced Grade 3/4 thrombocytopenia.
Slovenian: Trombocitopenija Pri približno 60 % bolnic, ki so prejemale zdravilo Zejula, se je pojavila trombocitopenija katere koli stopnje, pri 34 % bolnic pa se je pojavila trombocitopenija 3. ali 4. stopnje.
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).
Slovenian: Demografske značilnosti, izhodiščne lastnosti bolezni in anamneza predhodnih zdravljenj so bile na splošno dobro uravnotežene med krakoma z niraparibom in placebom v kohortah gBRCAmut
English: Myalgia
Slovenian: mialgija
English: No dose adjustment is needed in patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnicah z blago do zmerno okvaro jeter prilagoditev odmerka ni potrebna.
English: Therefore, the PRAC concluded that “febrile neutropenia” should be added as a new adverse drug reaction in section 4.8 of the SmPC with the frequency “uncommon.” The package leaflet should be updated accordingly.
Slovenian: Zato je odbor PRAC sklenil, da je treba v poglavju 4.8 povzetka glavnih značilnosti zdravila dodati nov neželeni učinek
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.
Slovenian: Če ste ženska v rodni dobi, morate uporabljati učinkovito kontracepcijo, dokler jemljete zdravilo Zejula in še 1 mesec po tem, ko ste vzeli zadnji odmerek.
English: • Resume Zejula at a reduced dose.
Slovenian: Ponovno začnite zdravljenje z zdravilom Zejula z zmanjšanim odmerkom.
English: Oxidative metabolism of niraparib is minimal in vivo.
Slovenian: Oksidativna presnova nirapariba in vivo je minimalna.
English: Therefore, no dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit P-gp (e.g. amiodarone, verapamil) or BCRP (e.g. osimertinib, velpatasvir, and eltrombopag).
Slovenian: Zato pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo P-gp (npr. amiodaron, verapamil) ali BCRP (npr. osimertinib, velpatasvir in eltrombopag), prilagoditev odmerka ni potrebna.
English: If there are other risk factors for bleeding such as co-administration of anticoagulation or antiplatelet medicinal products, consider interrupting these substances and/or transfusion at a higher platelet count.
Slovenian: Če so prisotni drugi dejavniki tveganja za krvavitev, kot je sočasno dajanje antikoagulacijskih ali antiagregacijskih zdravil,