natgillin/translations-raw huggingface dataset:
This is because it is not known if rucaparib passes into breast milk.
Ni namreč znano, ali rukaparib prehaja v materino mleko ali ne.
Other medicines and Rubraca
Druga zdravila in zdravilo Rubraca
Adverse reactions leading to permanent discontinuation occurred in 10% of patients, with thrombocytopenia, nausea, anaemia, and fatigue/asthenia being the most frequent adverse reactions leading to permanent discontinuation.
Neželeni učinki, ki so vodili do trajne prekinitve, so se pojavili pri 10 % bolnic, trombocitopenija, navzea, anemija in utrujenost/astenija pa so bili najpogostejši neželeni učinki, ki so vodili do trajne prekinitve.
For the maintenance treatment, patients should start the maintenance treatment with Rubraca no later than 8 weeks after completion of their final dose of the platinum containing regimen.
Pri vzdrževalnem zdravljenju morajo bolnice vzdrževalno zdravljenje z zdravilom Rubraca začeti najkasneje 8 tednov po zadnjem odmerku režima zdravljenja s platino.
In vitro, M324 was at least 30 fold less potent than rucaparib against PARP-1, PARP-2, and PARP-3.
In vitro je bil M324 vsaj 30-krat manj učinkovit od rukapariba proti PARP-1,
Caution should be exercised and additional International Normalised Ratio (INR) monitoring with co-administration of warfarin and therapeutic drug level monitoring of phenytoin should be considered, if used concomitantly with rucaparib.
Treba je razmisliti o dodatnem spremljanju vrednosti INR (internacionalno normalizirano razmerje) pri sočasnem dejanju varfarina in o spremljanju terapevtskih ravni fenitoina, če je uporabljen sočasno z rukaparibom.
Rucaparib accounted for 44.9% and 94.9% of radioactivity in urine and faeces, respectively; while M324 accounted for 50.0% and 5.1% of radioactivity in urine and faeces, respectively.
Rukaparib je predstavljal 44,9 % radioaktivnosti v urinu in 94,9 % v blatu, medtem ko je M324 predstavljal 50,0 % radioaktivnosti v urinu in 5,1 % v blatu.
Patients with germline (g)BRCA (n=88, 83.0%) or somatic (s)BRCA (n=18, 17.0%) mutations were included.
(g)BRCA (n = 88, 83,0 %) ali somatskimi mutacijami (s)BRCA (n = 18, 17,0 %).
If you stop taking Rubraca
Če ste prenehali jemati zdravilo Rubraca
No effects on male and female fertility were observed in 3-month general toxicology studies in rats and dogs at exposures of 0.09 to 0.3 times the human AUC at the recommended dose.
V 3-mesečni študiji splošne toksičnosti pri podganah in psih niso opazili učinkov na plodnost samcev in samic pri izpostavljenostih, ki so obsegale od 0,09- do 0,3-kratnik vrednosti AUC pri človeku ob priporočenem odmerku.
Rubraca can also be used if your cancer has progressed after chemotherapy has been used and you have an abnormality of the BRCA gene.
Zdravilo Rubraca je mogoče uporabljati tudi, če je rak po kemoterapiji napredoval in če imate nenormalnost v genu BRCA.
Rucaparib was not mutagenic in a bacterial reverse mutation (Ames) assay.
Rukaparib pri preizkusu reverzne mutacije pri bakterijah (Amesov test) ni bil mutagen.
Haematological adverse reactions of all CTCAE Grades of anaemia, thrombocytopenia and neutropenia were reported in 42%, 26% and 16% of patients respectively.
O hematoloških neželenih učinkih vseh stopenj po CTCAE, anemiji, trombocitopeniji in nevtropeniji, so poročali pri 42 %, 26 % oz. 16 % bolnic.
Talk to your doctor if you feel sick (nauseous), have been sick (vomiting) or you have had diarrhoea.
Pogovorite se z zdravnikom, če vam je slabo ali bruhate ali če ste imeli drisko.
• medicines to lower blood cholesterol levels- such as rosuvastatin
• zdravila za zniževanje ravni holesterola v krvi - npr. rosuvastatin,
Gastrointestinal toxicities (nausea and vomiting) are frequently reported with rucaparib, are generally low grade (CTCAE Grade 1 or 2), and may be managed with dose reduction (refer to Table 1) or interruption.
Pri zdravljenju z rukaparibom pogosto poročajo o gastrointestinalni toksičnosti (navzei in bruhanju), ki je običajno nizke stopnje (stopnje 1 ali 2 po CTCAE) in jo je mogoče obvladovati z zmanjšanjem odmerka (glejte Preglednico 1) ali s prekinitvijo zdravljenja.
The ORR, by independent radiology review for the platinum-sensitive population, was 42/79, 53.2% (95% CI [41.6-64.5]).
Stopnja objektivnega odziva po pregledu neodvisnega radiologa za populacijo, občutljivo na platino, je bila 42/79, 53,2 % (95-% IZ [41,6-64,5]).
In vitro, rucaparib was shown to be a substrate of P-gp and BCRP.
In vitro se je izkazalo, da je rukaparib substrat za P-gp in BCRP.
A potential risk cannot be ruled out based on the safety margin observed.
Glede na upoštevane varnostne omejitve potencialnega tveganja ni mogoče izključiti.
Adverse reactions may be managed through dose interruptions and/or dose reductions for moderate to severe reactions (i.e. CTCAE Grade 3 or 4) such as neutropenia, anaemia and thrombocytopenia.
Neželene učinke je mogoče obvladovati s prekinitvami odmerjanja in /ali z zmanjšanjem odmerkov v primeru zmernih do hudih učinkov (tj. stopnje 3 ali 4 po CTCAE), ko so npr. nevtropenija, anemija in trombocitopenija.
This is because Rubraca can cause low blood counts of:
To je nujno zato, ker zdravilo Rubraca lahko povzroči nizko število naslednjih krvnih celic:
A pregnancy test before initiating treatment is recommended in women of reproductive potential.
Pred uvedbo zdravljenja se pri ženskah v rodni dobi priporoča test nosečnosti.
Frequency of all CTCAE grades Frequency of CTCAE grade 3 and above
Pogostnost stopnje 3 in višjih po CTCAE
Limited data are available for patients with moderate or severe hepatic impairment (see section 4.2).
Za bolnice z zmerno ali hudo okvaro jeter so na voljo omejeni podatki (glejte poglavje 4.2).
PFS assessed by blinded independent radiology review (BIR) was a key secondary efficacy outcome.
Ključne sekundarne rezultate učinkovitosti predstavlja PFS po neodvisni slepi radiološki oceni (BIR).
Effects of rucaparib on other medicinal products
Vpliv rukapariba na druga zdravila
Concentration-QTcF prolongation analysis was conducted using data from 54 patients with a solid tumour administered continuous rucaparib at doses ranging from 40 mg once daily to 840 mg twice daily (1.4 times the approved recommended dose).
Analiza razmerja koncentracija-podaljšanje intervala QTcF je bila opravljena s pomočjo podatkov 54 bolnic s čvrstim tumorjem, ki so jim dajali stalne odmerke rukapariba od 40 mg enkrat na dan do 840 mg dvakrat na dan (1,4-kratnik odobrenega priporočenega odmerka).
Although in vitro rucaparib metabolism mediated by CYP3A4 was slow, a significant contribution of CYP3A4 in vivo cannot be excluded.
Čeprav je bila presnova rukapariba in vitro prek CYP3A4 počasna, ni mogoče izključiti pomembnega prispevka CYP3A4 in vivo.
No adjustment is recommended to the starting dose for elderly patients (≥ 65 years of age) (see sections 4.8 and 5.2).
Prilagoditve začetnega odmerka za starejše bolnice (≥ 65 let) niso priporočene (glejte poglavji 4.8 in
• feeling tired
Pogosti utrujenostc
Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e., preventative) use prior to starting Rubraca.
Za zdravljenje navzee/bruhanja je mogoče uporabiti tudi antiemetike, kot so npr. antagonisti 5-HT3, deksametazon, aprepitant in fosaprepitant; o teh zdravilih pa je mogoče razmišljati tudi v smislu profilakse (tj. preventivnega zdravljenja) pred uvedbo zdravljenja z zdravilom Rubraca.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Vomiting and nausea were reported in 42% and 77% of patients, respectively and were generally low grade (CTCAE Grade 1 to 3).
O bruhanju so poročali pri 42 %, o navzei pa pri 77 % bolnic, običajno sta bila nizke stopnje (stopnja od 1 do 3 po CTCAE).
Intravenous administration of rucaparib in the rat and dog induced cardiac effects at a high Cmax (5.4 to 7.3-fold higher than patients), but not at a lower Cmax (1.3 to 3.8-fold higher than patients).
Intravensko dajanje rukapariba podganam in psom je povzročilo učinke na srce pri visokih vrednostih Cmax (5,4- do 7,3-krat večje kot pri bolnicah), ne pa pri nizkih vrednostih Cmax (1,3- do 3,8- krat večje kot pri bolnicah).
No interaction with MRP2 or MRP3 was observed in vitro at the clinical exposure of rucaparib, however, mild bi-phasic activation and inhibition of MRP2 and concentration dependent inhibition of MRP3 were observed at concentrations higher than the observed plasma Cmax of rucaparib.
In vitro niso opazili nobenega medsebojnega delovanja z MRP2 ali z MRP3 pri klinični izpostavljenosti rukaparibu, opazili pa so blago bifazno aktivacijo in zaviranje MRP2 ter od koncentracije odvisno zaviranje MRP3 pri koncentracijah, višjih od ugotovljene plazemske vrednosti Cmax rukapariba.
Based on its mechanism of action and preclinical data, rucaparib may cause fetal harm when administered to a pregnant woman.
Glede na mehanizem delovanja in predklinične podatke lahko rukaparib škoduje plodu, če se uporablja pri nosečnici.
Increased alanine aminotransferase, Increased aspartate aminotransferase
Pogosti zvišane ravni alaninaminotransferaze, zvišane ravni aspartat-aminotransferaze
Randomisation was stratified by best response to last platinum therapy (complete or partial), time to progression following the penultimate platinum therapy (6 to ≤ 12 months and > 12
Randomizacija je bila stratificirana glede na najboljši odziv (popolni ali delni) na zadnjo terapijo na osnovi platine, čas do napredovanja bolezni po predzadnjem zdravljenju s platino (od 6 do ≤ 12
Interrupt rucaparib until values return to Grade ≤ 2; then resume rucaparib with a dose reduction and monitor LFTs weekly for 3 weeks
Zdravljenje z rukaparibom prekinite, dokler se vrednosti ne vrnejo na stopnjo ≤ 2; nato nadaljujte z dajanjem rukapariba v zmanjšanem odmerku in tedensko 3 tedne spremljajte izvide jetrnih preiskav.
Myelodysplastic syndrome/Acute myeloid leukaemia MDS/AML are serious adverse reactions that occur uncommonly (0.5%) in patients on treatment and during the 28 day safety follow up, and commonly (1.3%) for all patients including during the long term safety follow up (rate is calculated based on overall safety population of 1321 patients exposed to at least one dose of oral rucaparib in all clinical studies).
MDS/AML sta resna neželena učinka, ki se pojavljata občasno (0,5 %) pri bolnicah med zdravljenjem in v obdobju 28-dnevnega spremljanja varnosti in pogosto (1,3 %) pri vseh bolnicah, vključno z dolgoročnim spremljanjem varnosti (stopnja je izračunana na podlagi skupne populacije za vrednotenje varnosti zdravila, ki je zajemala 1321 bolnic, izpostavljenih najmanj enemu peroralnemu odmerku rukapariba v vseh kliničnih študijah).
Caution should be used when rucaparib is co-administered with UGT1A1 substrates (i.e. irinotecan) to patients with UGT1A1*28 (poor metabolizer) due to a possible increase in the exposure of SN-38 (the active metabolite of irinotecan) and associated toxicities.
Pri sočasnem dajanju rukapariba in substratov UGT1A1 (npr. irinotekana) bolnicam z UGT1A1*28 (slabe presnavljalke) je potrebna previdnost zaradi možnega povečanja izpostavljenosti SN-38 (aktivnemu presnovku irinotekana) in s tem povezanih toksičnosti.
Platinum-sensitive patients had received 2 (n=47, 59.5%), 3 (n=28, 35.4%), or > 3 (n=4, 5.1%) prior lines of platinumbased chemotherapy.
Bolnice z rakom, občutljivim na platino, so prejele 2 (n = 47, 59,5 %), 3 (n = 28, 35,4 %) ali > 3 (n = 4, 5,1 %) predhodne cikle kemoterapije na osnovi platine.
Most patients could continue rucaparib with or without treatment modification without recurrence of
Večina bolnic je z zdravljenjem z rukaparibom z ali brez prilagoditve zdravljenja lahko nadaljevala brez ponovnega pojava nenormalnosti jetrnih preiskav ≥ stopnje 3.
Interactions between rucaparib and oral contraceptives have not been studied.
Medsebojnega delovanja rukapariba in peroralnih kontraceptivov niso proučevali.
282 days (95% CI [218-335]), and the median overall survival was 18.8 months (95% CI [12.9-NA]).
Mediano preživetje brez napredovanja je bilo 282 dni (95-% IZ [218-335]), mediano celokupno preživetje pa 18,8 mesecev (95-% IZ [12,9-NA]).
• anticoagulant medicines which helps the blood flow freely, such as warfarin
• zdravila proti strjevanju krvi (antikoagulante), ki omogočajo neoviran pretok krvi - npr. varfarin,
Each bottle contains 60 film-coated tablets.
Ena plastenka vsebuje 60 filmsko obloženih tablet.
Then take your next dose at the usual time.
Nato vzemite naslednji odmerek ob predvidenem času.
During treatment with rucaparib, events of myelosuppression (anaemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8-10 weeks of treatment with rucaparib.
Med zdravljenjem z rukaparibom se lahko pojavijo učinki mielosupresije (anemija, nevtropenija, trombocitopenija), ki se običajno prvikrat pojavijo po 8-10 tednih zdravljenja z rukaparibom.
Hypercholesterolaemiab, Dehydration
Pogosti hiperholesterolemijab, dehidracija
In an embryo-foetal development study in rats, rucaparib was associated with post-implantation loss at exposures of approximately 0.04 times the human AUC at the recommended dose.
V študijah embrio-fetalnega razvoja pri podganah je bil rukaparib povezan z izgubo ploda po ugnezdenju pri izpostavljenostih, ki so približno ustrezale 0,04-kratniku vrednosti AUC pri človeku ob priporočenem odmerku.
This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Zdravilo je pridobilo tako imenovano "pogojno dovoljenje za promet".
• keep out of direct sunlight and not use sunbeds while you are taking Rubraca
• med jemanjem zdravila Rubraca izogibati neposredni sončni svetlobi in ne smete uporabljati solarijev.
Rubraca is used to treat a type of cancer of the ovary.
Zdravilo Rubraca uporabljamo za zdravljenje vrste raka jajčnikov.
Plasma exposures of rucaparib, as measured by Cmax and AUC, were approximately dose proportional at evaluated doses (40 to 500 mg daily, 240 to 840 mg twice a day).
Plazemske izpostavljenosti rukaparibu, merjene s Cmax in AUC, so bile za ocenjene odmerke (40 do 500 mg na dan, 240 do 840 mg dvakrat na dan) približno sorazmerne z odmerkom.
In patients with cancer following a high-fat meal, the Cmax increased by 20%, the AUC0-24h increased by 38%, and the Tmax was delayed by 2.5 hours, as compared with dosing under fasted conditions.
Pri bolnicah z rakom je po obroku z veliko vsebnostjo maščob vrednost Cmax narasla za 20 %, vrednost AUC0-24h za 38 %, vrednost Tmax se je podaljšala za 2,5 ure v primerjavi z odmerjanjem na tešče.
Patients should be advised to use effective contraception during treatment and for 6 months following the last dose of rucaparib.
Bolnicam je treba svetovati uporabo zanesljive kontracepcije med zdravljenjem in še 6 mesecev po prejemu zadnjega odmerka rukapariba.
• before treatment with Rubraca
• pred zdravljenjem z zdravilom Rubraca
Management of Treatment-emergent AST/ ALT Elevations Grade of AST/ALT Elevation
Uravnavanje zvišanj vrednost AST/ALT, ki se pojavijo med zdravljenjem Stopnja zvišanja vrednosti AST/ALT
Photosensitivity was reported in 13% of patients as low grade skin reactions (CTCAE Grade 1 or 2), and by 2 (0.2%) patients as ≥ CTCAE Grade 3 reaction.
O preobčutljivosti na svetlobo so poročali pri 13 % bolnic kot o kožnem učinku nizke stopnje (stopnja CTCAE 1 ali 2), pri 2 (0,2 %) bolnicah pa kot o učinku stopnje CTCAE 3.
• If you forget to take a dose, skip the missed dose.
• Če ste pozabili vzeti odmerek, ga preskočite.
Rucaparib has been shown to have in vitro and in vivo anti-tumour activity in BRCA mutant cell lines through a mechanism known as synthetic lethality, whereby the loss of two DNA repair pathways is required for cell death.
Ugotovljeno je bilo, da rukaparib zavira tumorsko dejavnost in vitro in in vivo v mutantskih celičnih linijah BRCA prek mehanizma, imenovanega sintezna smrtnost, pri katerem je potrebna izguba dveh poti popravila DNA, da pride do celične smrti.
Rucaparib Placebo
Placebo Rukaparib
• medicines used to relax muscles - such as tizanidine
• zdravila, ki jih uporabljamo za sproščanje mišic - npr. tizanidin,
None of the patients had received prior treatment with a PARP inhibitor.
Nobena bolnica ni predhodno prejela zdravljenja z zaviralci PARP.
• medicines which suppress the immune system - such as ciclosporin, sirolimus or tacrolimus
• zdravila za zaviranje imunskega sistema - npr. ciklosporin, sirolimus ali takrolimus,
• medicines to treat allergic reactions - such as astemizole or terfenadine
• zdravila za zdravljenje alergijskih reakcij - npr. astemizol ali terfenadin,
Patients included in the population PK study were aged 21 to 86 years (58% < 65 years, 31% 65-74 years, and 11% > 75 years), 82% were Caucasian, and had body weights between 41 and 171 kg (73% had body weight > 60 kg).
Bolnice, ki so bile vključene v študijo populacijske farmakokinetike, so bile stare od 21 do 86 let (58 % < 65 let, 31 % od 65 do 74 let in 11 % > 75 let), 82 % jih je bilo bele rase, njihova telesna teža pa je bila med 41 in 171 kg (73 % jih je imelo telesno težo > 60 kg).
ARIEL3 Efficacy Results Parameter
Preglednica 4: Rezultati za učinkovitost na podlagi študije ARIEL3
• medicines to treat severe pain - such as alfentanil or fentanyl
• zdravila za zdravljenje hudih bolečin - npr. alfentanil ali fentanil,
Summary of primary efficacy findings for patients with BRCA-mutant ovarian cancer who received rucaparib 600 mg twice daily and two or more prior chemotherapy regimens based on investigator assessment of response
Povzetek primarnih ugotovitev o učinkovitosti pri bolnicah z rakom jajčnikov zaradi mutacij gena BRCA, ki so prejemale rukaparib 600 mg dvakrat na dan in so imele v preteklosti dva ali več režimov terapije na podlagi ocene odziva, ki ga oceni raziskovalec Primarna populacija študije učinkovitosti
The median progression-free survival was 162 days (95% CI [51-223]).
Mediano preživetje brez napredovanja bolezni je bilo 162 dni (95-% IZ [51-223]).
ORR was similar for patients with germline BRCA-mutant ovarian cancer or somatic BRCA-mutant ovarian cancer and for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
ORR je bil podoben pri bolnicah z rakom jajčnikov zaradi germinalne mutacije BRCA ali somatske mutacije BRCA in pri bolnicah z mutacijo gena BRCA1 ali z mutacijo gena BRCA2.
Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anaemia and neutropenia.
Za korigiranje nizkega števila krvnih celic je treba uvesti podporno zdravljenje v skladu s smernicami ustanove za zdravljenje anemije in nevtropenije.
Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor.
Učinkovitosti zdravila Rubraca pri zdravljenju recidivnega ali napredujočega EOC, FTC ali PPC pri bolnicah, ki so bile pred tem zdravljene z zaviralcem PARP, niso preučili.
There are no clinical data in patients with severe renal impairment (CLcr less than 30 mL/min), therefore rucaparib is not recommended for use in patients with severe renal impairment.
Kliničnih podatkov pri bolnicah s hudo okvaro ledvic ni (vrednost CLcr nižja od 30 ml/min), zato uporaba rukapariba ni priporočljiva pri bolnicah s hudo okvaro ledvic.
Rubraca has minor influence on the ability to drive and use machines.
Zdravilo Rubraca ima blag vpliv na sposobnost vožnje in upravljanja strojev.
If you forget to take Rubraca
Če ste pozabili vzeti zdravilo Rubraca
• medicines used to treat uncontrolled movement or mental disorders - such as pimozide
• zdravila za zdravljenje nenadzorovanih gibov ali duševnih motenj - npr. pimozid,
Rucaparib also marginally inhibits P-gp in the gut.
Rukaparib tudi marginalno zavira P-gp v prebavilih.
In patients with cancer, rucaparib had a steady-state volume of distribution of 113 L to 262 L following a single intravenous dose of 12 mg to 40 mg rucaparib.
Pri bolnicah z rakom je imel volumen porazdelitve rukapariba v stanju dinamičnega ravnovesja od 113 l do 262 l po enkratnem intravenskem odmerku rukapariba od 12 mg do 40 mg.
If you take more tablets than you should, tell your doctor, pharmacist or nurse straight away.
Če ste vzeli večji odmerek tablet, kot bi smeli, morate takoj obvestiti zdravnika, farmacevta ali medicinsko sestro.
Caution should be used for concomitant use of strong CYP3A4 inhibitors or inducers.
Pri sočasni uporabi močnih zaviralcev ali induktorjev CYP3A4 je potrebna previdnost.
Median duration of responsea - days (95% CI)
Mediano trajanje odzivaa - dnevi (95-odstotni IZ)
Because of the potential for serious adverse reactions in breast-fed infants from rucaparib, breast-feeding is contraindicated during treatment with Rubraca and for 2 weeks after the final dose (see section 4.3).
Zaradi možnih resnih neželenih učinkov rukapariba pri dojenih otrocih je dojenje med zdravljenjem z zdravilom Rubraca in še 2 tedna po zadnjem odmerku kontraindicirano (glejte poglavje 4.3).
Following administration of a single oral dose of [14C]-rucaparib 600 mg to patients, the overall mean recovery of radioactivity was 89.3%, with a mean recovery of 71.9% in faeces and 17.4% in urine by 288 hours post dose.
Po dajanju enega samega 600 mg peroralnega odmerka [14C]-rukapariba bolnikom je bilo skupno mediano izločanje radioaktivnosti 89,3 %, od tega je mediano izločanje 71,9 % z blatom in 17,4 % z urinom po 288 urah po odmerjanju.
Based on the animal studies, impact on fertility associated with the use of rucaparib cannot be ruled out (see section 5.3).
Podatkov o učinku rukapariba na plodnost pri človeku ni. Na podlagi študij na živalih učinka na plodnost, povezanega z uporabo rukapariba, ni mogoče izključiti (glejte poglavje 5.3).
In patients ≥ 75 years old, frequencies of some adverse reactions increased: increased blood creatinine (32%), dizziness (20%), pruritus (15%), and memory impairment (4%) were higher than in patients < 75 years old (18%, 15%, 9% and 1% respectively).
Pri bolnicah, starih ≥ 75 let, so bile pogostnosti nekaterih neželenih učinkov, vključno s povišanjem kreatinina v krvi (32 %), omotico (20 %), pruritusom (15 %) in poslabšanjem spomina (4 %), pogostejše kot pri bolnicah, starih < 75 let (18 %, 15 %, 9 % oziroma 1 %).
In addition, according to its mechanism of action rucaparib may have the potential to impair fertility in humans.
Poleg tega ima morda rukaparib glede na mehanizem delovanja potencial za škodljive učinke na plodnost pri ljudeh.
• medicines used to cause sleepiness or drowsiness - such as midazolam
• zdravila, ki jih uporabljamo za povzročanje zaspanosti ali dremavosti - npr. midazolam,
In the subset of 79 platinum-sensitive patients, progression free interval after last platinum dose was ≥ 6 - 12 months for 55 (69.6%) patients and > 12 months for 24 (30.4%) patients.
V podpopulaciji 79 bolnic z rakom, občutljivim na platino, je interval brez napredovanja bolezni po zadnjem odmerku platine znašal ≥ 6-12 mesecev pri 55 (69,6 %) bolnicah in > 12 mesecev pri 24
HR (95% CI) p-valueb a. All randomised patients.
Vrednost pb a. Vse randomizirane bolnice.
Rucaparib down regulated CYP2B6 in human hepatocytes at clinically relevant exposures.
Rukaparib je CYP2B6 pri klinično pomembnih izpostavljenostih v človeških human hepatocitih reguliral navzdol.
Increased ALT was observed in 34.8% (all grades) and 9.9% (≥ CTCAE Grade 3) of patients, increased AST in 31.4% (all grades) and 2.8% (≥ CTCAE Grade 3) of patients and increased ALT and AST in 28.6% (all grades) and 2.1% (≥ CTCAE Grade 3) of patients.
Zvišanje ALT so opažali pri 34,8 % (vse stopnje) in 9,9 % (≥ stopnja CTCAE 3) bolnic, zvišanje AST pri 31,4 % (vse stopnje) in 2,8 % (≥ stopnja CTCAE 3) bolnic, zvišanje ALT in AST pa pri 28,6 % (vse stopnje) in 2,1 % (≥ stopnja CTCAE 3) bolnic.
CYP1A2 substrates
Substrati CYP1A2
Increased blood creatinine, Hypercholesterolaemiab
Občasni zvišane ravni kreatinina v krvi, hiperholesterolemijab
Fatiguec, Pyrexia
Zelo pogosti utrujenostc, pireksija