natgillin/translations-raw huggingface dataset:
The recommended dose is 600 mg rucaparib taken twice daily, equivalent to a total daily dose of 1,200 mg, until disease progression or unacceptable toxicity.
Priporočeni odmerek je 600 mg rukapariba dvakrat na dan, kar ustreza celotnemu dnevnemu odmerku 1.200 mg, jemati pa ga je treba do napredovanja bolezni ali do nesprejemljive toksičnosti.
Rubraca should not be used during pregnancy unless the clinical condition of the woman requires treatment with rucaparib.
Zdravila Rubraca se med nosečnostjo ne sme uporabljati, razen če klinično stanje nosečnice zahteva zdravljenje z rukaparibom.
Four (0.4%) patients reported a CTCAE Grade 3 reaction.
Pri štirih (0,4 %) bolnicah so poročali o učinku stopnje CTCAE 3.
The mean half-life (t1/2) of rucaparib was 25.9 hours.
Mediani razpolovni čas (t1/2) rukapariba je bil 25,9 ur.
Patients were randomised within 8 weeks of completion of platinum chemotherapy and no intervening maintenance treatment was permitted.
Bolnice so bile randomizirane v 8 tednih od zaključka kemoterapije na osnovi platine, dovoljeno pa ni bilo nikakršno interventno vzdrževalno zdravljenje.
• If you are sick (vomit) after taking Rubraca, do not take an extra dose.
- Če vam je slabo (bruhate) po tem, ko ste vzeli zdravilo Rubraca, ne vzemite dodatnega odmerka.
Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare
Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (<1/10.000), neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
No events met Hy's Law criteria for drug-induced liver injury.
Nobeden od dogodkov ni ustrezal merilom Hyjevega zakona za poškodbe jeter zaradi zdravil.
Elevations in serum creatinine
Zvišane ravni kreatinina v serumu
The European Medicines Agency has waived the obligation to submit the results of studies with Rubraca in all subsets of the paediatric population in ovarian cancer (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Rubraca za vse podskupine pediatrične populacije pri raku jajčnikov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• a low blood-cell count may be a sign of a serious bone marrow problem - such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
• nizko število krvnih celic je lahko znak resnejše težave s kostnim mozgom, na primer „mielodisplastičnega sindroma“ (MDS) ali “akutne mieloične levkemije“ (AML).
Decreased appetite, Dehydration
Pogosti zmanjšan apetit, dehidracija
No significant P-gp inhibition was observed in vivo (section 4.5).
In vivo niso opazili pomembnega zaviranja P-gp (poglavje 4.5).
ARIEL3 demonstrated a statistically significant improvement in PFS for patients randomised to rucaparib as compared with placebo in the ITT population and in the HRD and tBRCA subgroups.
Študija ARIEL3 je pokazala statistično značilno izboljšanje PFS pri bolnicah, randomiziranih v rukaparib, v primerjavi s placebom pri populaciji ITT in v podskupinah HRD ter tBRCA.
Women of childbearing potential/contraception in females
Ženske v rodni dobi/kontracepcija pri ženskah
Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Zdravniku, farmacevtu ali medicinski sestri morate povedati, če jemljete katero od naslednjih zdravil:
Kaplan-Meier Curves of Progression-Free Survival in ARIEL3 as Assessed by Investigator: ITT population
Slika 1: Kaplan-Meierjeve krivulje preživetja brez napredovanja bolezni pri ARIEL3 po oceni raziskovalca - populacija ITT
If the levels have not recovered to CTCAE Grade 1 or better after 4 weeks, the patient should be referred to a haematologist for further investigations.
Če se vrednosti v 4 tednih ne popravijo vsaj na stopnjo 1 po CTCAE, je treba bolnico napotiti k hematologu na nadaljnje preiskave.
In the pivotal Phase 3 study (ARIEL3), the incidence of MDS/AML during therapy in patients who received rucaparib was 0.8%.
V ključni študiji 3. faze (ARIEL3) je pojavnost MDS/AML med zdravljenjem pri bolnicah, ki so prejemale rukaparib, znašala 0,8 %.
months), and tumour biomarker status (tBRCA, non-BRCA homologous recombination deficiency [nbHRD] and biomarker negative).
mesecev in več kot 12 mesecev) ter statusa biomarkerja za tumor (tBRCA, homologno rekombinatorno pomanjkanje, ki ni povezano z BRCA [nbHRD] in negativni biomarker).
HDPE bottle, with a polypropylene (PP) induction seal closure, containing 60 tablets.
Plastenka iz HDPE z indukcijsko zapečateno zaporko iz propilena (PP), ki vsebuje 60 tablet.
Rubraca is for oral use and can be taken with or without food.
Zdravilo Rubraca je namenjeno za peroralno uporabo in ga je mogoče jemati s hrano ali brez nje.
• use a sunscreen and lip balm with a sun protection factor (SPF) of 50 or higher.
• zaščititi s sredstvom za zaščito pred soncem in z balzamom za ustnice z zaščitnim faktorjem (SPF) 50 ali več.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http:// www.ema.europa.eu.
Patients with moderate or severe renal impairment should be carefully monitored for renal function and adverse reactions.
Bolnice z zmerno ali hudo okvaro ledvic je treba skrbno spremljati glede delovanja ledvic in neželenih učinkov.
Rucaparib preferentially distributed to red blood cells with a blood-to-plasma concentration ratio of 1.83.
Rukaparib se je prednostno porazdelil v rdeče krvničke, razmerje koncentracij v krvi in plazmi je bilo 1,83.
Ninety percent of the observed faecal recovery was achieved within 168 hours postdose.
Devetdeset odstotkov izločka v blatu je bilo zaznanega v 168 urah po odmerjanju.
• The other ingredients are:
Druge sestavine zdravila so:
Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib.
O mielodisplastičnem sindromu/akutni mieloični levkemiji (MDS/AML), vključno s primeri s smrtnim izidom, so poročali pri bolnicah, ki so prejemale rukaparib.
If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.
Če je po preiskavi dolgotrajnejše hematološke toksičnosti potrjena diagnoza MDS/AML, je treba zdravljenje z zdravilom Rubraca prekiniti.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom, preden vzamete to zdravilo.
• The usual recommended dose is 600 mg twice a day.
- Običajni priporočeni odmerek je 600 mg dvakrat na dan.
Dose adjustments may be considered, if clinically indicated based on observed adverse reactions.
Morda bo treba razmišljati o prilagoditvi odmerkov, če bo to klinično indicirano glede na opažene neželene učinke.
• Do not take a double dose to make up for a forgotten dose.
• Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Other moderate to severe non-haematological adverse reactions such as nausea and vomiting, can be managed through dose interruption and/or reductions, if not adequately controlled by appropriate symptomatic management.
Druge zmerne do hude nehematološke neželene učinke, kot sta npr. navzea ali bruhanje, je mogoče obvladovati s prekinitvijo in/ali zmanjšanji odmerkov, če jih z ustreznim simptomatskim zdravljenjem ni mogoče zadovoljivo obvladati.
Tumour tissue samples for all of the patients (N=564) were tested centrally to determine HRD positive status (as defined by the presence of a deleterious tumour BRCA [tBRCA] mutation or high genomic loss of heterozygosity).
Vzorec tumorskih tkiv vseh bolnic (N = 564) je bil centralno testiran za ugotavljanje pozitivnega stanja HRD (ki ga opredeljuje prisotnost mutacije škodljivega tumorja BRCA [tBRCA] ali visoke genomske izgube heterozigotnosti).
If you take Rubraca because your cancer has progressed you will need to have a clinical test to identify an abnormality in the BRCA gene.
Če zdravilo Rubraca jemljete, ker je vaš rak napredoval, boste morali na klinično preiskavo za ugotavljanje nenormalnosti v genu BRCA.
Grade 1-3 elevations in AST/ALT can be managed without change to the rucaparib dose, or with treatment modification (interruption and/or dose reduction).
Zvišane ravni AST/ALT stopenj od 1 do 3 je mogoče obvladovati brez spreminjanja odmerka rukapariba ali s prilagoditvijo zdravljenja (prekinitev in/ali zmanjšanje odmerka).
The risk for a clinically relevant effect of concomitant administration of proton pump inhibitors (PPIs) is likely small (see section 5.2).
Verjetno je tveganje za klinično pomembne učinke sočasnega dajanja zaviralcev protonske črpalke (proton pump inhibitors - PPI) majhno (glejte poglavje 5.2).
Detection of BRCA mutation
Zaznava mutacije BRCA
Pregnancy/contraception
Nosečnost/kontracepcija
Rucaparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair.
Rukaparib je zaviralec encimov poli(ADP-riboza) polimeraze (PARP), vključno s PARP-1, PARP-2 in PARP-3, ki sodelujejo pri popravilu DNA.
The median duration of response was 196 days (95% CI [113 - NA]).
Mediano trajanje odziva je bilo 196 dni (95-% IZ [113 - NA]).
As such, efficacy of Rubraca in patients who have received prior treatment with a PARP inhibitor in the maintenance setting, has not been investigated and cannot be extrapolated from the available data.
Učinkovitost zdravila Rubraca pri bolnicah, ki so predhodno prejemale vzdrževalno zdravljenje z zaviralcem PARP, zato ni bila raziskana in je ni mogoče ekstrapolirati iz razpoložljivih podatkov.
Following administration of a single oral dose of [14C]-rucaparib to patients with solid tumours, unchanged rucaparib accounted for 64.0% of the radioactivity in plasma.
Po dajanju enega samega peroralnega odmerka [14C]-rukapariba bolnikom s solidnimi tumorji je nespremenjen rukaparib predstavljal 64,0 % radioaktivnosti v plazmi.
In addition, rucaparib is an inhibitor of the BCRP with IC50 value suggesting potential BCRP inhibition and increased exposures of medicinal products that are BCRP substrates (e.g., rosuvastatin).
Poleg tega je rukaparib zaviralec BCRP z vrednostjo IC50, ki kaže na potencialno zaviranje BCRP in povečano izpostavljenosti zdravilom, ki so substrati BCRP (npr. rosuvastatin).
The pharmacokinetic characteristics of rucaparib in patients with CLcr less than 30 mL/min or patients on dialysis are unknown (see section 4.2).
Farmakokinetične značilnosti rukapariba pri bolnicah s CLcr manj kot 30 ml/min ali pri bolnicah na dializi niso znane (glejte poglavje 4.2).
AST/ALT elevations may need to be managed with treatment interruption and/or dose reduction as described in Table 2 (see section 4.2).
Zvišane ravni AST/ALT bo morda treba uravnavati s prekinitvijo zdravljenja in/ali zmanjšanjem odmerka, kot je predstavljeno v preglednici 2 (glejte poglavje 4.2).
This is because rucaparib may affect the unborn baby.
To je nujno zato, ker lahko rukaparib škoduje nerojenemu otroku.
All patients had received at least two prior platinum-based chemotherapies (range: 2 to 6) and 28% of patients had received at least three prior platinum-based chemotherapies.
Vse bolnice so prejele vsaj dve predhodni kemoterapiji na osnovi platine (razpon: 2-6), 28 % bolnic pa je prejelo vsaj tri predhodne kemoterapije na osnovi platine.
If MDS/AML is suspected, the patient should be referred to a haematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics.
Če sumite na pojav MDS/AML, morate bolnico napotiti k hematologu na nadaljnje preiskave, vključno z analizo kostnega mozga in z odvzemom vzorca krvi za citogenetsko analizo.
Elevations in creatinine with rucaparib treatment may be due to inhibition of the renal transporters MATE1 and MATE2-K (see section 4.5).
Do zvišanih ravni kreatinina pri zdravljenju z rukaparibom lahko prihaja zaradi zaviranja ledvičnih prenašalcev MATE1 in MATE2-K (glejte poglavje 4.5).
If you take more Rubraca than you should
Če ste vzeli večji odmerek zdravila Rubraca, kot bi smeli
The findings in non-clinical toxicology studies performed with oral rucaparib were generally consistent with the adverse events observed in clinical studies.
Ugotovitve nekliničnih toksikoloških študij, izvedenih s peroralnim rukaparibom, so bile v splošnem skladne z neželenimi učinki, ugotovljenimi v kliničnih študijah.
Thrombocytopenia and anaemia led to discontinuation in 1.8% and 2.1% of patients.
Trombocitopenija in anemija sta vodili v prekinitev zdravljenja pri 1,8 % in 2,1 % bolnic.
The mean absolute oral bioavailability following a single oral dose of 12 to 120 mg rucaparib was 36%.
Mediana absolutna peroralna biološka uporabnost po enkratnem peroralnem odmerku od 12 do 120 mg rukapariba je bila 36 %.
What Rubraca is and what it is used for What you need to know before you take Rubraca How to take Rubraca
Kaj je zdravilo Rubraca in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Rubraca Kako jemati zdravilo Rubraca
Although no cardiac effects were observed following oral dosing, based on the findings in the intravenous studies and safety margins, cardiac effects in patients cannot be excluded when rucaparib is given orally.
Čeprav po peroralnem odmerjanju niso opazili učinkov na srce, pa na podlagi izsledkov iz študij z intravenskim dajanjem in na podlagi varnostnih omejitev ni mogoče izključiti učinkov na srce pri bolnicah, ki peroralno prejemajo rukaparib.
The primary tumour in most patients was ovarian (84%); most patients (95%) had serous histology and 4% of patients reported endometrioid histology.
Primarni tumor pri večini bolnic je bil tumor jajčnikov (84 %); večina bolnic (95 %) je imela serozno histologijo in pri 4 % bolnic so poročali o endometrijski histologiji.
Patients should not start Rubraca treatment until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1).
Bolnice ne smejo začeti zdravljenja z zdravilom Rubraca, dokler ne okrevajo po hematotoksičnih učinkih predhodne kemoterapije (stopnje ≤ 1 po CTCAE).
This is because Rubraca can affect the way some other medicines work.
Zdravilo Rubraca namreč lahko vpliva na delovanje nekaterih drugih zdravil.
Grade 4 reactions require treatment modification (see Table 2).
Učinki stopnje 4 zahtevajo prilagoditev zdravljenja (glejte preglednico 2).
Also some other medicines can affect the way Rubraca works.
Tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Rubraca.
Increases in serum creatinine, predominantly mild to moderate (CTCAE Grade 1 or 2), were observed in 20% of patients within the first few weeks of treatment with rucaparib.
Zvišane ravni kreatinina v serumu, večinoma blage do zmerne (stopnje 1 ali 2 po CTCAE), so opažali pri 20 % bolnic v prvih tednih zdravljenja z rukaparibom.
PFS events, n (%) PFS, median in months (95% CI)
Dogodki PFS, n (%) PFS, mediana v mesecih (95-% IZ)
Rubraca should be interrupted or dose reduced according to Table 1 (see section 4.2) and blood counts monitored weekly until recovery.
Zdravljenje z zdravilom Rubraca je treba prekiniti ali zmanjšati odmerek zdravila v skladu s Preglednico 1 (glejte poglavje 4.2), krvno sliko pa spremljati na tedenski osnovi do okrevanja.
Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient.
Do zvišanih ravni jetrnih transaminaz (aspartat-aminotransferaze (AST) in/ali alanin-aminotransferaze (ALT)) prihaja v zgodnjem obdobju zdravljenja in so običajno prehodne narave.
In vitro studies have shown that rucaparibinduced cytotoxicity involves inhibition of PARP enzymatic activity and the trapping of PARP-DNA complexes resulting in increased DNA damage, apoptosis, and cell death.
Študije in vitro so pokazale, da z rukaparibom povzročena toksičnost vključuje zaviranje encimske dejavnosti PARP in preprečevanje sprostitve kompleksov PARP-DNA, kar povzroči povečane okvare DNA, apoptozo in celično smrt.
The progression-free interval to penultimate platinum therapy was 6-12 months in 39% of patients and > 12 months in 61%.
Interval brez napredovanja bolezni za predzadnjim zdravljenjem s platino je bil 6-12 mesecev pri 39 % in > 12 mesecev pri 61 % bolnic.
Effect of other medicinal products on rucaparib
Vpliv drugih zdravil na rukaparib
As inhibition of these transporters could increase metformin renal elimination and decrease liver uptake of metformin, caution is advised when metformin is co-administered with rucaparib.
Ker bi zaviranje teh prenašalcev lahko povečalo izločanje metformina prek ledvic in zmanjšalo jetrni privzem metformina, je ob sočasnem dajanju metformina z rukaparibom priporočena previdnost.
In an animal reproduction study, administration of rucaparib to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see section 5.3).
V študiji razmnoževanja pri živalih je dajanje rukapariba brejim podganam v obdobju organogeneze povzročilo embrio-fetalno toksičnost pri izpostavljenostih, nižjih od izpostavljenosti pri bolnicah, ki so prejemale priporočeni odmerek za človeka 600 mg dvakrat na dan (glejte poglavje 5.3).
Abdominal pain (combined terms abdominal pain, abdominal pain lower, abdominal pain upper) was reported in 40.1% of rucaparib treated patients, but was also very common (33%) in placebo patients, most likely associated with underlying disease.
O bolečinah v trebuhu (skupno poimenovanje za bolečine v trebuhu, bolečine v spodnjem delu trebuha, bolečine v zgornjem delu trebuha) so poročali pri 40,1 % bolnic, ki so se zdravile z rukaparibom, zelo pogoste (33 %) pa so bile tudi pri bolnicah, zdravljenih s placebom, kar je najverjetneje povezano z osnovnimi boleznimi.
Interaction of rucaparib with other enzymes and transporter was evaluated in vitro.
Medsebojno delovanje rukapariba z drugimi encimi in prenašalci so ocenjevali in vitro.
Rucaparib has been shown to decrease tumour growth in mouse xenograft models of human cancer with or without deficiencies in BRCA.
Dokazali so, da rukaparib zmanjšuje rast tumorjev v ksenografskih modelih humanega raka pri miših z ali brez pomanjkanja BRCA.
The time of onset for adverse reactions of myelosuppression Grade 3 or higher was generally later in treatment (after 2 or more months).
Do nastopa neželenih učinkov mielosupresije stopnje 3 ali višje je običajno prišlo v kasnejšem obdobju zdravljenja (po 2 ali več mesecih).
All patients had achieved a response (complete or partial) to their most recent platinum-based chemotherapy and their cancer antigen 125 (CA-125) was below the upper limit of normal (ULN).
Vse bolnice so bile odzivne (popolnoma ali delno) na svojo zadnjo kemoterapijo na osnovi platine, njihov rakasti antigen 125 (CA-125) je bil pod zgornjo mejo normalne vrednosti (ULN).
No dose adjustment is considered necessary for co-administered medicinal products that are CYP2C19 substrates.
Prilagoditve odmerka med sočasno uporabo zdravil, ki so substrati CYP2C19, niso potrebne.
For risk mitigation and management, see section 4.4.
Za ukrepe za izogibanje tveganju in za obvladovanje tveganja glejte poglavje 4.4.
Rubraca can be used as maintenance therapy immediately after a course of chemotherapy that has caused the tumour to shrink.
Zdravilo Rubraca je mogoče uporabljati kot vzdrževalno zdravilo takoj po kemoterapiji, ki je povzročila krčenje tumorja.
The proportion of platinum-sensitive patients with gBRCA and sBRCA mutations was comparable to the primary efficacy population at n=66 (83.5%) and n=13 (16.5%) respectively.
občutljivim na platino, z mutacijami gBRCA in sBRCA je bil primerljiv s primarno populacijo študije učinkovitosti z n = 66 (83,5 %) in n = 13 (16,5 %).
Take your next dose at your regular time.
Svoj naslednji odmerek vzemite ob predvidenem času.
The mean age was 61 years (range: 36 to 85); most of the patients were white (80%); and all had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Povprečna starost je bila 61 let (razpon: 36-85); večina bolnic je pripadala beli rasi (80 %); vse pa so imele stanje zmogljivosti po Eastern Cooperative Oncology Group (ECOG) 0 ali 1.
The duration of therapy with rucaparib in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.
Pri bolnicah, ki so zbolele za MDS/AML, je zdravljenje z rukaparibom trajalo od manj kot 1 meseca do približno 28 mesecev.
Contents of the pack and other information What Rubraca contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Rubraca
Rubraca must not be used during breast-feeding.
Zdravila Rubraca se med dojenjem ne sme uporabljati.
Pyrexia a MDS/AML rate is based on overall total patient population of 1321 who have received one dose of oral rucaparib.
Občasni pireksija a Stopnja MDS/AML temelji na skupni populaciji 1321 bolnic, ki so prejele en peroralni odmerek rukapariba.
Events related to increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were observed in 38% (all grades) and 11% (≥ CTCAE Grade 3) of patients.
Dogodke, povezane z zvišanimi ravnmi alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST), so opažali pri 38 % (vse stopnje) in 11 % (≥ stopnja CTCAE 3) bolnic.
For the platinum-resistant population (N=20), ORR by investigator review was 35.0% (95% CI [15.4, 59.2], with a complete response rate of 5.0%, and a partial response rate of 30.0%.
Za populacijo, odporno na platino (N=20), je bila stopnja objektivnega odziva po pregledu raziskovalca 35,0 % (95-% IZ [15,4; 59,2], s stopnjo popolnega odziva 5,0 % in stopnjo delnega odziva 30,0 %.
Your doctor may test your bone marrow to check for any problems.
Zdravnik bo pri vas morda opravil preiskavo kostnega mozga, da bo raziskal morebitne težave.
a The median duration of response is determined from the patients who had an objective tumour response according to RECIST guidelines, following treatment with rucaparib.
a Mediano trajanje odziva je bilo določeno glede na bolnice, ki so imele po zdravljenju z rukaparibom objektivni odziv tumorja glede na smernice RECIST.
Medicinal product interactions
Medsebojno delovanje zdravil
Based on population PK analysis, no clinically significant relationships were identified between predicted steady-state exposure and patient's age, race, and body weight.
Na podlagi populacijske farmakokinetične analize niso ugotovili klinično pomembnih razmerij med predvideno izpostavljenostjo v stanju dinamičnega ravnovesja in bolničino starostjo, raso in telesno maso.
At clinical exposures, rucaparib did not inhibit bile salt export pump (BSEP), OATP1B1, OATP1B3, OAT1 and OAT3.
Pri kliničnih izpostavljenostih rukaparib ni zaviral eksportne črpalke žolčnih soli (BSEP - bile salt export pump), OATP1B1, OATP1B3, OAT1 in OAT3.
Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised.
Preiskavo s celotno krvno sliko je priporočljivo opraviti pred zdravljenjem z zdravilom Rubraca, nato pa vsak mesec.
Rubraca is an anti-cancer medicine, also known as a ‘PARP (poly adenosine diphosphate-ribose polymerase) inhibitor'.
Zdravilo Rubraca je zdravilo proti raku, imenovano tudi „zaviralec PARP (poli [adenozin-difosfat-riboza] polimeraza)“.
What Rubraca is and what it is used for What Rubraca is and how it works
Kaj je zdravilo Rubraca in za kaj ga uporabljamo Kaj je zdravilo Rubraca in kako deluje