FrancophonIA/ELRC3.0 huggingface dataset:
English: In a population PK analysis, no clinically relevant PK differences were observed among patients with different CYP2D6 phenotypes (including poor metabolizers, n=9; intermediate metabolizers, n=71; normal metabolizers, n=76; and ultra-rapid metabolizers, n=4) or patients with different CYP1A2 phenotypes (including normal metabolizers, n=28; hyperinducers, n=136).
Slovenian: V analizi populacijske farmakokinetike niso opazili razlik med bolnicami z različnimi fenotipi CYP2D6 (vključno s slabimi presnavljalkami, n = 9; srednjimi presnavljalkami, n = 71; normalnimi presnavljalkami, n = 76 in ultrahitrimi presnavljalkami, n = 4) ali med bolnicami z različnimi fenotipi CYP1A2 ( vključno z normalnimi presnavljalkami, n = 28; hiperinduktorji, n = 136).
English: • medicines to lower blood sugar levels and treat diabetes - such as metformin
Slovenian: • zdravila za zniževanje ravni sladkorja v krvi in za zdravljenje sladkorne bolezni - npr.
English: Increased rucaparib-induced cytotoxicity and anti-tumour activity was observed in tumour cell lines with deficiencies in BRCA1/2 and other DNA repair genes.
Slovenian: V tumorskih celičnih linijah so opazili povečano citotoksičnost in protitumorsko delovanje ter pomanjkanje BRCA1/2 in drugih genov za popravilo DNK.
English: Caution is advised when co-administering medicinal products that are CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine).
Slovenian: Ob sočasnem dajanju zdravil, ki so substrati CYP3A z ozkim terapevtskim indeksom (npr. alfentanil, astemizol, cisaprid, ciklosporin, dihidroergotamin, ergotamin, fentanil, pimozid, kinidin, sirolimus, takrolimus, terfenadin) je potrebna previdnost.
English: In a medicinal product interaction study in cancer patients, the effects of steady-state rucaparib at 600 mg twice daily on CYP1A2, CYP2C9, CYP2C19, CYP3A, and P-gp were evaluated with single oral doses of sensitive probes (caffeine, S-warfarin, omeprazole, midazolam, and digoxin, respectively).
Slovenian: V študiji medsebojnega delovanj zdravil, v kateri so sodelovale bolnice z rakom, so ocenjevali učinke rukapariba v stanju dinamičnega ravnovesja ob odmerku 600 mg, dvakrat na dan, na CYP1A2, CYP2C9, CYP2C19, CYP3A in P-gp z enkratnimi peroralnimi odmerki občutljivih substratov (kofein, S-varfarin, omeprazol, midazolam in digoksin).
English: In vitro, rucaparib is an inhibitor of the BCRP and P-gp efflux transporters.
Slovenian: In vitro je rukaparib zaviralec BCRP in efluksnih prenašalcev Pgp.
English: Rubraca is supplied in plastic bottles.
Slovenian: Zdravilo Rubraca je na voljo v plastenkah.
English: Women of reproductive potential should be advised to use effective contraception during treatment and for 6 months following the last dose of Rubraca (see section 4.6).
Slovenian: Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem in še 6 mesecev po zadnjem odmerku zdravila Rubraca uporabljajo učinkovito kontracepcijo (glejte poglavje 4.6).
English: Carcinogenicity studies have not been performed with rucaparib.
Slovenian: Študij karcinogenosti z rukaparibom niso opravili.
English: When co-administering medicinal products metabolized by CYP1A2, particularly medicines which have a narrow therapeutic index (e.g., tizanidine, theophylline), dose adjustments may be considered based on appropriate clinical monitoring.
Slovenian: Ob sočasnem dajanju zdravil, ki se presnavljajo prek izoencima CYP1A2, še zlasti zdravil z ozkim terapevtskim indeksom (npr. tizanidin, teofilin), bo morda treba razmisliti o prilagoditvi odmerkov na podlagi ustreznega kliničnega spremljanja.
English: Dose adjustments for adverse reactions
Slovenian: Prilagoditve odmerka zaradi neželenih učinkov
English: There are limited clinical data in patients with moderate or severe hepatic impairment (ie, any total bilirubin greater than 1.5 times ULN), therefore rucaparib is not recommended for use in patients with moderate or severe hepatic impairment.
Slovenian: Klinični podatki pri bolnicah z zmerno ali hudo okvaro jeter (tj. vsakršna skupna vrednost bilirubina, večja od 1,5-kratne vrednosti ULN) so omejeni, zato uporaba rukapariba ni priporočljiva pri bolnicah z zmerno ali hudo okvaro jeter.
English: Before taking Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC, patients must have confirmation of deleterious germline or somatic mutations in the breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene using a validated test.
Slovenian: Pred začetkom jemanja zdravila Rubraca pri zdravljenju recidivnega ali napredovalega EOC, FTC ali PPC je treba pri bolnicah potrditi škodljive germinalne ali somatske mutacije gena dovzetnosti za raka dojk 1 (BRCA1) ali gena dovzetnosti za raka dojk 2 (BRCA2) z validirano testno metodo.
English: A population PK analysis was performed to evaluate the effect of renal impairment on the clearance of rucaparib in patients receiving rucaparib 600 mg twice daily.
Slovenian: Populacijska farmakokinetična analiza je bila opravljena z namenom ocene učinka okvare jeter na očistek rukapariba pri bolnicah, ki so prejemale rukaparib v odmerku 600 mg dvakrat na dan.
English: Caution when driving or using machines is advised for patients who report fatigue, nausea, or dizziness during treatment with Rubraca (see section 4.8).
Slovenian: Bolnice, ki med zdravljenjem z zdravilom Rubraca poročajo o utrujenosti, navzei ali omotici, morajo biti previdne pri vožnji in upravljanju strojev (glejte poglavje 4.8).
English: Inhibition of MRP4 by rucaparib cannot be fully ruled out at clinical exposures.
Slovenian: Zaviranja MRP4 s strani rukapariba pri kliničnih izpostavljenostih ni mogoče v celoti izključiti.
English: Rucaparib is a weak inhibitor of CYP2C8, CYP2D6, and UGT1A1.
Slovenian: Rukaparib je šibek zaviralec CYP2C8, CYP2D6 in UGT1A1.
English: In vitro, rucaparib was shown to be a substrate of P-gp and BCRP, but not a substrate of renal uptake transporters OAT1, OAT3, and OCT2, or hepatic transporters OAPT1B1 and OATP1B3.
Slovenian: Podatki in vitro so pokazali, da je rukaparib substrat P-gp in BCRP, ni pa substrat ledvičnih privzemnih prenašalcev OAT1, OAT3 in OCT2 ali jetrnih prenašalcev OAPT1B1 in OATP1B3.
English: PAES: In order to further investigate the efficacy of rucaparib maintenance treatment in patients with relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy, the MAH should submit the final analysis of OS and updated analyses of PFS2, chemotherapy-free interval and time to start of subsequent anti-cancer treatment of the phase 3, randomised, double-blind study CO-338-014
Slovenian: PAES: Za nadaljnje raziskovanje učinkovitosti vzdrževalnega zdravljenja z rukaparibom pri bolnicah z recidivnim epitelijskim rakom jajčnikov, jajcevodov ali primarnim peritonealnim rakom visoke stopnje, ki se (v celoti ali delno) odzivajo na kemoterapijo s platino, bo imetnik dovoljenja za promet predložil končno analizo OS in posodobljene analize PFS2, intervala brez kemoterapije in časa do začetka nadaljnjega zdravljenja raka iz randomizirane dvojno slepe študije 3. faze CO-338-014.
English: The clinical relevance of UGT1A1 inhibition by rucaparib is not clear.
Slovenian: UGT1A1 s strani rukapariba ni jasen.
English: d. tBRCA includes all patients with a deleterious germline or somatic BRCA mutation, as determined by the CTA.
Slovenian: d. tBRCA vključuje vse bolnice s škodljivo zarodno linijo celic ali somatsko mutacijo BRCA, ugotovljeno s kliničnim preskušanjem.
English: Rubraca may affect your ability to drive or use tools or machines.
Slovenian: Zdravilo Rubraca lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
English: At the predicted median steady-state Cmax following 600 mg rucaparib twice daily, the projected QTcF increase from baseline was 11.5 msec (90% CI: 8.77 to 14.2 msec).
Slovenian: Ob pričakovanem medianem Cmax v stanju dinamičnega ravnovesja po dajanju rukapariba v odmerku 600 mg dvakrat na dan je predvideno podaljšanje intervala QTcF od izhodišča znašalo 11,5 msec (90-odstotni IZ: 8,77 do 14,2 msec).
English: Rucaparib showed no effect on Cmax of caffeine while moderately increasing AUCinf of caffeine by 2.55 fold (90% CI: 2.12, 3.08).
Slovenian: Rukaparib ni kazal nikakršnega učinka na Cmax kofeina, je pa zmerno povišal AUCinf kofeina za 2,55-krat (90-odstotni IZ: 2,12, 3,08).
English: The tumour histology was high grade serous in 91.5% of patients, endometrioid in 2.8% and mixed histology in 4.7%.
Slovenian: Histologija tumorja je bila pri 91,5 % bolnic serozni karcinom visoke stopnje, pri 2,8 % endometrioidni karcinom, pri 4,7 % bolnic pa je bila histologija mešana.
English: The efficacy of rucaparib was investigated in ARIEL3, a double-blind, multicentre clinical trial in which 564 patients with recurrent EOC, FTC or PPC who were in response to platinum-based chemotherapy were randomized (2:1) to receive Rubraca tablets 600 mg orally twice daily (n=375) or placebo (n=189).
Slovenian: Vzdrževalno zdravljenje recidivnega raka jajčnikov Učinkovitost rukapariba so raziskovali v dvojno slepem, multicentričnem kliničnem preskušanju ARIEL3, v katerem je sodelovalo 564 bolnic s ponavljajočimi se EOC, FTC ali PPC in z odzivnostjo na kemoterapijo na osnovi platine, randomiziranih (2 : 1) za prejemanje tablet zdravila Rubraca 600 mg peroralno dvakrat na dan (n = 375) oziroma placeba (n = 189).
English: HR (95% CI) p-valueb
Slovenian: HR (95-% IZ) Vrednost pb
English: Potential in vivo BCRP inhibition cannot be excluded.
Slovenian: Potenciala za in vivo zaviranje BCRP ni mogoče izključiti.
English: No studies have been conducted to investigate the pharmacokinetics of rucaparib in paediatric patients.
Slovenian: Študije za preučevanje farmakokinetike rukapariba pri pediatričnih bolnikih niso bile opravljene.
English: Adverse reactions that most commonly led to dose reduction or interruption were anaemia (20%), fatigue/asthenia (18%), nausea (16%), thrombocytopenia (15%), and AST/ALT elevations (10%).
Slovenian: Neželeni učinki, ki so najpogosteje vodili do zmanjšanja odmerka ali prekinitve zdravljenja, so bili anemija (20 %), utrujenost/astenija (18 %), navzea (16 %), trombocitopenija (15 %) in zvišanje ravni ALT/AST (10 %).
English: If a patient vomits after taking Rubraca, the patient should not retake the dose and should take the next scheduled dose.
Slovenian: Če bolnica po zaužitju zdravila Rubraca bruha, ne sme znova vzeti odmerka, pač pa vzame šele naslednji načrtovani odmerek.
English: Rucaparib induced structural chromosomal aberrations in the in vitro human lymphocyte chromosomal aberration assay.
Slovenian: Rukaparib je povzročil strukturne kromosomske aberacije in vitro testu kromosomskih aberacij v človeških levkocitih.
English: • medicines to treat stomach problems - such as cisapride, omeprazole
Slovenian: • zdravila za zdravljenje težav z želodcem - npr. cisaprid, omeprazol,
English: There are no or limited data from the use of rucaparib in pregnant women.
Slovenian: O uporabi rukapariba pri nosečnicah ni podatkov oziroma so ti omejeni.
English: Increased transaminases
Slovenian: Pogosti zvišane ravni transaminazb
English: • anticonvulsant medicines used to treat fits (seizures) and epilepsy - such as phenytoin
Slovenian: • zdravila, ki jih uporabljamo za zdravljenje napadov krčev (epileptičnih napadov) in epilepsije (antikonvulzivi) - npr. fenitoin,
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
English: Decreased appetite, Increased blood creatinineb
Slovenian: Zelo pogosti zmanjšan apetit, zvišane ravni kreatinina v krvib
English: • being short of breath, feeling tired, having pale skin, or fast heart beat - these may be signs of a low red blood cell count (anaemia)
Slovenian: - kratka sapa, občutek hude utrujenosti, bledica kože ali hitro bitje srca - to so lahko znaki nizkega števila rdečih krvnih celic (anemije), - podplutbe ali krvavitve, ki trajajo dlje kot po navadi, če se poškodujete - to so lahko znaki nizkega števila krvnih ploščic (trombocitopenije), - vročina ali okužba - to sta lahko znaka nizkega števila belih krvnih celic (nevtropenije);
English: The primary efficacy outcome was investigator-assessed progression-free survival (invPFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1).
Slovenian: Response Evaluation Criteria in Solid Tumors), različica 1.1 (v1.1).
English: When co-administering medicinal products that are CYP2C9 substrates with a narrow therapeutic index (e.g., warfarin, phenytoin), dose adjustments may be considered, if clinically indicated.
Slovenian: Ob sočasnem dajanju zdravil, ki so substrati CYP2C9 z ozkim terapevtskim indeksom (npr. varfarin, fenitoin), bo morda treba razmisliti o prilagoditvi odmerkov, če bo to klinično indicirano.
English: What Rubraca looks like and contents of the pack
Slovenian: Izgled zdravila Rubraca in vsebina pakiranja
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Rubraca.
Slovenian: Če ste negotovi, se pred začetkom jemanja zdravila Rubraca posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: • Tablet content: Microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica and magnesium stearate.
Slovenian: • Vsebina tablete: Mikrokristalna celuloza, natrijev karboksimetilškrob (vrsta A), brezvodni koloidni silicijev dioksid in magnezijev stearat
English: The most abundant metabolite was M324, an oxidative deamination product of rucaparib, accounting for 18.6% of the radioactivity in plasma.
Slovenian: Največ je bilo presnovka M324, ki je produkt oksidativne deaminacije rukapariba in ki je v plazmi predstavljal
English: No clinically important differences were observed between 34 patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin > 1.0 to 1.5 times ULN and any AST) and 337 patients with normal hepatic function.
Slovenian: Med 34 bolnicami z blago okvaro jeter (skupni bilirubin ≤ ULN in AST > ULN ali skupni bilirubin > 1,0- do 1,5-kratnik ULN in kakršna koli AST) in 337 bolnicami z normalnim delovanjem jeter niso opazili nobenih klinično pomembnih razlik.
English: Rucaparib showed no effect on Cmax of digoxin while marginally increasing AUC0-72h by 1.20 fold (90% CI: 1.12 to 1.29).
Slovenian: Rukaparib ni pokazal nikakršnega učinka na Cmax digoksina in je marginalno povišal AUC0-72 h za 1,20-krat (90-odstotni IZ: 1,12 do 1,29).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Rubraca Vsebina pakiranja in dodatne informacije
English: In vitro, rucaparib reversibly inhibited CYP1A2, CYP2C19, CYP2C9, and CYP3A, and to a lesser extent CYP2C8, CYP2D6, and UGT1A1.
Slovenian: In vitro je rukaparib povratno zaviral CYP1A2, CYP2C19, CYP2C9 in CYP3A, v manjši meri pa tudi CYP2C8, CYP2D6 in UGT1A1.
English: • Rubraca is available as either 200 mg, 250 mg or 300 mg tablets.
Slovenian: - Zdravilo Rubraca je na voljo v obliki 200-miligramskih, 250-miligramskih ali 300-miligramskih tablet.
English: The ≥ Grade 3 adverse reactions occurring in > 5% of patients were anaemia (23%), ALT elevations (10%), fatigue/asthenia (10%), neutropenia (8%), thrombocytopenia (6%), and nausea (5%).
Slovenian: Neželeni učinki stopnje ≥ 3, ki so se pojavili pri > 5 % bolnic, so bili anemija (23 %), zvišanje ravni ALT (10 %), utrujenost/astenija (10 %), nevtropenija (8 %), trombocitopenija (6 %) in navzea (5 %).
English: Patients should avoid spending time in direct sunlight because they may burn more easily during rucaparib treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor (SPF) of 50 or greater.
Slovenian: Ko so zunaj, naj bolnice nosijo klobuk in zaščitna oblačila, uporabljajo naj preparate za zaščito pred soncem in balzam za ustnice z zaščitnim faktorjem (SPF) 50 ali več.
English: b Includes laboratory findings c Includes fatigue, asthenia and lethargy
Slovenian: c Vključuje utrujenost, astenijo in letargijo.
English: Microcrystalline cellulose Sodium starch glycolate (Type A) Colloidal anhydrous silica Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza natrijev karboksimetilškrob (vrsta A) brezvodni koloidni silicijev dioksid magnezijev stearat
English: The in vitro protein binding of rucaparib is 70.2% in human plasma at therapeutic concentration levels.
Slovenian: Vezava rukapariba v človeški plazmi v območju terapevtskih koncentracij in vitro je 70,2 %.
English: In an exploratory analysis in this subgroup, a response was noted in 18% (95% CI 12% - 26%) of patients (n=26) on rucaparib compared to 8% (95% CI 3% - 17%) of patients (n=5) on placebo (2-sided p-value = 0.0069), including 10 patients (7%) in the rucaparib group who achieved a complete remission.
Slovenian: V eksplorativni analizi te podskupine so odziv ugotovili pri 18 % (95-odstotni IZ 12 % - 26 %) bolnic (n = 26), ki so prejemale rukaparib, v primerjavi z 8 % (95-odstotni IZ 3 % - 17 %) bolnic (n = 5), ki so prejemale placebo (dvostranska p-vrednost = 0,0069), vključno z 10 bolnicami (7 %) v skupini, ki je prejemala rukaparib, ki so dosegle popolno remisijo.
English: Data suggest that rucaparib is a moderate inhibitor of CYP1A2, and a mild inhibitor of CYP2C9, CYP2C19, and CYP3A.
Slovenian: Podatki kažejo na to, da je rukaparib zmeren zaviralec izoencima CYP1A2 in blag zaviralec izoencimov CYP2C9, CYP2C19 in CYP3A.
English: 60 film-coated tablets.
Slovenian: 60 filmsko obloženih tablet
English: The adverse reaction frequency is listed by MedDRA System Organ Class (SOC) at the preferred term level.
Slovenian: Pogostnost neželenih učinkov je predstavljena z uporabo razvrstitve pogostnosti CIOMS III ter so navedeni po organskem sistemu po MedDRA in na ravni prednostnega izraza.
English: Treatment of BRCA-mutated ovarian cancer after 2 or more chemotherapies The efficacy of rucaparib was investigated in 106 patients in 2 multicentre, single-arm, open-label clinical studies, Study 10 and ARIEL2, in patients with advanced BRCA-mutant epithelial ovarian, fallopian tube or primary peritoneal cancer who had progressed after 2 or more prior chemotherapies (the primary efficacy population).
Slovenian: Učinkovitost rukapariba so preiskovali pri 106 bolnicah v 2 multicentričnih, odprtih kliničnih študijah z enim krakom, Study 10 in ARIEL2, pri bolnicah z napredovalim epitelijskim rakom jajčnikov, jajcevodov ali primarnim peritonealnim rakom z mutacijo na genu BRCA, pri katerih je bolezen po 2 ali več predhodnih kemoterapijah napredovala (primarna populacija študije učinkovitosti) .
English: Patients with Renal Impairment
Slovenian: Bolnice z ledvično okvaro
English: Most of the primary efficacy population were platinum-sensitive (n=79, 74.5%); the remaining patients were platinum-resistant (n=20, 18.9%) or platinum-refractory (n=7, 6.6%).
Slovenian: = 79, 74,5 %), preostale bolnice pa so imele raka, ki je bil odporen na platino (n = 20, 18,9 %) ali neodziven na platino (n = 7, 6,6 %).
English: Leukopeniab, Lymphopeniab, Febrile neutropenia
Slovenian: Pogosti levkopenijab, limfopenijab, febrilna nevtropenija
English: In patients with cancer following rucaparib 600 mg taken twice daily, the mean steady-state Cmax was 1940 ng/mL and AUC0-12h was 16900 h⋅ng/mL with Tmax of 1.9 hours.
Slovenian: Pri bolnicah z rakom je po jemanju rukapariba v odmerku 600 mg dvakrat na dan mediana vrednost Cmax v stanju dinamičnega ravnovesja znašala 1940 ng/m, vrednost AUC 0-12 h pa 16.900 h⋅ng/ml s Tmax 1,9 ure.
English: Objective response rate (ORR) N
Slovenian: Stopnja objektivnega odziva (ORR) n % (95-odstotni IZ)
English: Platinum Sensitive N=79
Slovenian: N = 79
English: In vitro, rucaparib is metabolised primarily by CYP2D6, and to a lesser extent by CYP1A2, and CYP3A4.
Slovenian: In vitro se rukaparib presnavlja primarno prek CYP2D6, v manjšem obsegu pa še prek CYP1A2 in CYP3A4.
English: Adverse reactions CTCAE Grade 3 or higher occurred in 23% (anaemia), 8% (neutropenia) and 6% (thrombocytopenia) of patients.
Slovenian: Neželeni učinki stopnje 3 po CTCAE so se pojavili pri 23 % (anemija), 8 % (nevtropenija) in 6 % (trombocitopenija) bolnic.
English: CYP2C19 substrates
Slovenian: Substrati CYP2C19
English: • medicines to treat irregular heartbeats - such as digoxin or quinidine
Slovenian: • zdravila za zdravljenje nerednega srčnega utripa - npr. digoksin ali kinidin,
English: Tabulated list of adverse reactions by MedDRA system organ class Adverse reactions
Slovenian: Preglednica 3: Tabelarični pregled neželenih učinkov v skladu s klasifikacijo MedDRA po organskih sistemih
English: In an exploratory analysis, a response was noted in 38% (95% CI 23% - 54%) of patients (n=15) on rucaparib compared to 9% (95% CI 1%28%) of patients (n=2) on placebo (2-sided p-value = 0.0055), including 7 (18%) patients in the rucaparib group who achieved a complete remission.
Slovenian: V eksplorativni analizi te podskupine so odziv ugotovili pri 38 % (95-odstotni IZ 23 % - 54 %) bolnic (n = 15), ki so prejemale rukaparib, v primerjavi z 9 % (95-odstotni IZ 1 % - 28 %) bolnic (n = 2) v skupini, ki je prejemala placebo (dvostranska p-vrednost = 0,0055), vključno s 7 (18 %) bolnicami v skupini, ki so dosegle popolno remisijo.
English: In vitro, the IC50 of rucaparib against the human ether-à-go-go related gene (hERG) was 22.6 µM, which is approximately 13-fold higher than the Cmax in patients at the recommended dose.
Slovenian: In vitro je vrednost IC50 rukapariba proti hERG (human ether-à-go-go related gene) znašala 22,6 µM,
English: Grade ≥ 3 LFT abnormalities.
Slovenian: PARP-2 in PARP-3.
English: Oxidation, N-demethylation, N-methylation, glucuronidation, and N-formylation were the major metabolic pathways for rucaparib.
Slovenian: Glavne presnovne poti za rukaparib so bile oksidacija, N-demetilacija, N-metilacija, glukuronidacija in N-formilacija.
English: Rubraca can be administered with or without food.
Slovenian: Zdravilo Rubraca se lahko daje s hrano ali brez nje.
English: Study 10 population characteristics in 42 patients were: median age 57 years (range 42 to 84), white (83%), ECOG performance status 0 (62%) or 1 (38%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (36%), median time since ovarian cancer diagnosis 43 months [range: 6178], median progression-free interval from the last platinum treatment 8.0 months [range: 6.0
Slovenian: Značilnosti populacije v študiji Study 10 z 42 bolnicami so bile: mediana starost 57 let (razpon od 42 do 84 let), belke (83 %), stanje zmogljivosti po ECOG 0 (62 %) ali 1 (38 %), rak jajčnikov visoke stopnje (100 %), 3 ali več predhodnih ciklov kemoterapije (36 %), mediani čas od diagnoze raka jajčnikov 43 mesecev (razpon: 6-178), mediani interval brez napredovanja bolezni od zadnjega zdravljenja s platino 8,0 mesecev (razpon: 6,0-116,4).
English: Yellow, 8 x 16 mm, oval film-coated tablet, debossed with “C3”.
Slovenian: Rumena, ovalna filmsko obložena tableta velikosti 8 x 16 mm, z oznako "C3"c2.
English: Based on in vitro data, CYP2D6, and to a lesser extent CYP1A2 and CYP3A4, were able to metabolize rucaparib.
Slovenian: Na podlagi podatkov in vitro so izoencim CYP2D6, v manjši meri pa tudi izoencima CYP1A2 in CYP3A4, uspešno presnavljali rukaparib.
English: • The active substance is rucaparib.
Slovenian: • Učinkovina zdravila Rubraca je rukaparib.
English: Interrupt treatment if AST/ALT levels do not decline within 2 weeks until Grade ≤ 2, then resume rucaparib at the same or at a reduced dose
Slovenian: 2 tednih ne upadejo na stopnjo ≤ 2, in nato nadaljujte z dajanjem rukapariba v istem ali zmanjšanem odmerku.