natgillin/translations-raw huggingface dataset:
• medicines which suppress the immune system - such as ciclosporin, sirolimus or tacrolimus
• lijekove koji potiskuju imunološki sustav - kao što je ciklosporin, sirolimus ili takrolimus
The median progression-free survival was 162 days (95% CI [51-223]).
Medijan preživljenja bez progresije bio je 162 dana (95 % IP [51-223]).
Based on the animal studies, impact on fertility associated with the use of rucaparib cannot be ruled out (see section 5.3).
Rezultati iz ispitivanja na životinjama pokazali su da se utjecaj na plodonost povezan s primjenom rukapariba ne može isključiti. (vidjeti dio 5.3).
The progression-free interval to penultimate platinum therapy was 6-12 months in 39% of patients and > 12 months in 61%.
Interval bez progresije bolesti za pretposljednju terapiju platinom iznosio je 6 - 12 mjeseci u 39 % bolesnica te > 12 mjeseci u 61 % njih.
Rubraca can be administered with or without food.
Rubraca se može primjenjivati sa ili bez hrane.
What you need to know before you take Rubraca Do not take Rubraca:
Što morate znati prije nego počnete uzimati lijek Rubraca Nemojte uzimati lijek Rubraca:
• abnormal blood tests - increase in blood creatinine levels
• abnormalni rezultati krvnih pretraga - povišene razine kreatinina u krvi
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).
U populacijskoj PK analizi nisu uočene klinički relevantne PK razlike među bolesnicama s različitim CYP2D6 fenotipovima. (uključujući slabe metabolizatore, n=9; intermedijarne metabolizatore, n=71; normalne metabolizatore, n=76; i vrlo brze metabolizatore, n=4) ili pacijente s različitim CYP1A2 fenotipovima (uključujući normalne metabolizatore, n=28; hiperinduktore, n=136).
Recommended dose adjustments Dose reduction
Preporučene prilagodbe doze Smanjenje doze
• medicines used to relax muscles - such as tizanidine
• lijekove koji se koriste za opuštanje mišića - kao što je tizanidin
• medicines to lower blood sugar levels and treat diabetes - such as metformin
• lijekove za smanjenje razina šećera u krvi i za liječenje dijabetesa - kao što je metformin
Enzymes responsible for rucaparib metabolism have not been identified.
Nisu identificirani enzimi koji su odgovorni za metabolizam rukapariba.
Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib.
Mijelodisplastični sindrom/akutna mijeloična leukemija Mijelodisplastični sindrom/akutna mijeloična leukemija (MDS/AML), uključujući slučajeve sa smrtnim ishodom, prijavljeni su u bolesnica koje su primale rukaparib.
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 odnosa koncentracije i produljenja QTcF provedena je upotrebom podataka od 54 bolesnice sa solidnim tumorom kojima su primjenjivane kontinuirane doze rukapariba u rasponu od 40 mg jednom dnevno do 840 mg dva puta dnevno (1,4 puta više od odobrene preporučene doze).
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).
Potreban je oprez kod istodobne primjene lijekova uskog terapijskog indeksa koji su supstrati CYP3A (npr. alfentanila, astemizola, cisaprida, ciklosporina, dihidroergotamina, ergotamina, fentanila, pimozida, kinidina, sirolimusa, takrolimusa, terfenadina).
• 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)
• nedostatak zraka, osjećaj umora, blijeda koža ili ubrzani otkucaji srca - to mogu biti znakovi niskog broja eritrocita (anemija)
No dose adjustment is considered necessary for co-administered medicinal products that are CYP2C19 substrates.
Smatra se da nije potrebna prilagodba doze za istodobno primjenjivane lijekove koji su supstrati CYP2C19.
At clinical exposures, rucaparib did not inhibit bile salt export pump (BSEP), OATP1B1, OATP1B3, OAT1 and OAT3.
Pri kliničkim izloženostima, rukaparib nije inhibirao pumpu za izbacivanje žučnih soli (engl. bile salt export pump, BSEP), OATP1B1, OATP1B3, OAT1 i OAT3.
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 bio sličan za bolesnice koje su imale rak jajnika s germinativnim BRCA mutacijama ili somatskim BRCA mutacijama i za bolesnice s mutacijom BRCA1 gena ili mutacijom BRCA2 gena.
There are no data on the effect of rucaparib on human fertility.
Ne postoje podaci o učinku rukapariba na plodnost kod ljudi.
• The active substance is rucaparib.
• Djelatna tvar je rukaparib.
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.
Nuspojave se mogu zbrinjavati prekidima primjene doza i/ili smanjenjima doza kod umjerenih do teških reakcija (tj. CTCAE 3. ili 4. stupnja) kao što je neutropenija, anemija ili trombocitopenija.
• high cholesterol levels
• visoke razine kolesterola
No cardiac effects were observed with oral dosing of rucaparib in repeat-dose toxicology studies at a rucaparib Cmax comparable to that observed in patients.
Nikakvi kardiološki učinci nisu uočeni pri peroralnim dozama rukapariba u toksikološkim ispitivanjima ponovljenih doza pri vrijednosti Cmax rukapariba usporedivoj s onom primjećenom u pacijenata.
It is unknown whether rucaparib/or its metabolites are excreted in human milk.
Nije poznato izlučuje li se rukaparib ili njegovi metaboliti u majčino mlijeko.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving rucaparib.
Žene u reproduktivnoj dobi treba savjetovati da izbjegavaju trudnoću dok primaju lijek rukaparib.
If you forget to take Rubraca
Ako ste zaboravili uzeti lijek Rubraca
In vitro, rucaparib was shown to be a substrate of P-gp and BCRP.
In vitro, rukaparib se pokazao kao supstrat P-gp i BCRP.
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.
Nuspojave koje su dovele do trajnog prestanka primjene pojavile su se u 10 % bolesnika, a trombocitopenija, mučnina, anemija i umor/astenija bile su najčešće nuspojave koje su dovele do trajnog prestanka primjene.
• medicines to treat allergic reactions - such as astemizole or terfenadine
• lijekove za liječenje alergijskih reakcija - kao što je astemizol ili terfenadin
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.
Bolesnice s rakom osjetljivim na platinu primile su 2 (n=47; 59,5 %), 3 (n=28; 35,4 %) ili > 3 (n=4; 5,1 %) prethodne linije kemoterapije na bazi platine.
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.
Pokazalo se da rukaparib in vitro i in vivo ima antitumorsku aktivnost u staničnim linijama s BRCA mutacijama putem mehanizma poznatog kao sintetička smrtnost, u kojima je za smrt stanice potreban gubitak dva puta popravka DNK-a.
You may get sunburn more easily during treatment with Rubraca.
Možete mnogo lakše dobiti opekline tijekom liječenja lijekom Rubraca.
Increased rucaparib-induced cytotoxicity and anti-tumour activity was observed in tumour cell lines with deficiencies in BRCA1/2 and other DNA repair genes.
Povećana protutumorska aktivnost i citotoksičnost uzrokovana rukaparibom uočeni su u linijama tumorskih stanica s nedostacima gena BRCA1/2 i drugih gena za popravak DNK.
Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the rucaparib and placebo arms.
Demografija, karakteristike bolesti na početku ispitivanja i anamneza prethodne terapije općenito su bili dobro uravnoteženi između skupine koja je primala rukaparib i skupine koja je primala placebo.
• medicines to treat severe pain - such as alfentanil or fentanyl
• lijekove protiv snažnih bolova - kao što je alfentanil ili fentanil
This is because it is not known if rucaparib passes into breast milk.
To je stoga što nije poznato izlučuje li se rukaparib u majčino mlijeko.
Grade 4
4. stupanj
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.
Stoga nije ispitana djelotvornost lijeka Rubraca u bolesnica koje su primile prethodnu terapiju inhibitorom PARP-a u okviru terapije održavanja te se ne može ekstrapolirati iz dostupnih podataka.
Limited data are available for patients with moderate or severe hepatic impairment (see section 4.2).
Dostupni su ograničeni podaci za bolesnice s umjerenim ili teškim oštećenjem funkcije jetre (vidjeti dio 4.2).
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).
Zbog potencijalnih ozbiljnih nuspojava rukapariba kod dojenčadi, dojenje je kontraindicirano tijekom liječenja lijekom Rubraca i 2 tjedna nakon posljednje doze (vidjeti dio 4.3).
Fatiguec, Pyrexia
Vrlo često umorc, pireksija
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.
Prije uzimanja lijeka Rubraca kao terapije za relapsni ili progresivni EOC, FTC ili PPC, bolesnice moraju imati potvrdu o štetnim germinativnim ili somatskim mutacijama u genu raka dojke 1 (BRCA1) ili genu raka dojke 2 (BRCA2) primjenom validiranog testa.
There are no animal studies on the excretion of rucaparib in breast milk.
Ne postoje ispitivanja na životinjama o izlučivanju rukapariba u majčino mlijeko.
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).
PK analizu populacije bile su u dobi od 21 do 86 godina (58 % < 65 godina, 31 % 65 - 74 godine i 11 % > 75 godina), 82 % su bile bijele rase, s tjelesnom težinom između 41 i 171 kg (73 % je imalo tjelesnu težinu > 60 kg).
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.
Ne postoje klinički podaci u bolesnica s teškim oštećenjem funkcije bubrega (CLcr manji od 30 ml/min), stoga se rukaparib ne preporučuje za primjenu u bolesnica s teškim oštećenjem funkcije bubrega.
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.
Antiemetici, poput 5-HT3 antagonista, deksametazona, aprepitanta i fosaprepitanta, mogu se koristiti za liječenje mučnine/povraćanja, a mogu se također razmotriti za profilaktičnu (tj.
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.
Omjer bolesnica s rakom osjetljivim na platinu s gBRCA i sBRCA mutacijama bio je usporediv s populacijom za ocjenu primarnog ishoda djelotvornosti pri n=66 (83,5 %) odnosno n=13 (16,5 %).
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.
Nakon primjene jedne oralne doze [14C]-rukapariba od 600 mg kod bolesnika ukupna srednja vrijednost oporavka radioaktivnosti iznosila je 89,3 %, pri čemu je srednja vrijednost oporavka u fecesu iznosila 71,9 %, a u urinu 17,4 % do 288 sati nakon doze.
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.
U bolesnica s rakom, rukaparib u stanju dinamičke ravnoteže ima volumen distribucije od 113 l do 262 l nakon jedne intravenske doze od 12 mg do 40 mg rukapariba.
Rucaparib has been shown to decrease tumour growth in mouse xenograft models of human cancer with or without deficiencies in BRCA.
Pokazalo se da rukaparib smanjuje rast tumora u mišjim modelima ksenografta ljudskog karcinoma s nedostacima gena BRCA ili bez njih.
Effects of rucaparib on other medicinal products
Učinci rukapariba na druge lijekove
• bleeding or bruising for longer than usual if you hurt yourself - these may be signs of a low blood platelet count (thrombocytopenia)
• krvarenje ili modrice koji traju dulje nego što je uobičajeno nakon ozljede - to mogu biti znakovi niskog broja trombocita (trombocitopenija)
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).
Žene u reproduktivnoj dobi moraju se upozoriti o upotrebi djelotvorne kontracepcije tijekom liječenja i 6 mjesec nakon posljednje doze lijeka Rubraca (vidjeti dio 4.6).
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.
Nisu opažene klinički važne razlike između 34 bolesnice s blagim oštećenjem funkcije jetre (ukupni bilirubin ≤ GGN i AST > GGN ili ukupni bilirubin > 1,0 do 1,5 puta GGN i bilo koja vrijednost AST-a) i 337 bolesnica s normalnom funkcijom jetre.
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).
Djelotvornost rukapariba ispitana je u dvostruko slijepom, multicentričnom kliničkom ispitivanju ARIEL3 u sklopu kojega su 564 bolesnice s recidivirajućim EOC-om, FTC-om ili PPC-om koje su postigle odgovor na kemoterapiju na bazi platine randomizirane (2:1) u skupine za peroralnu terapiju Rubraca tabletama od 600 mg dvaput dnevno (n = 375) ili placebom (n = 189).
Interrupt rucaparib until values return to Grade ≤ 2; then resume rucaparib with a dose reduction and monitor LFTs weekly for 3 weeks
Prekid primjene rukapariba dok se vrijednosti ne vrate na ≤ 2. stupanj; zatim nastavak primjene rukapariba uz smanjenje doze i tjedno praćenje testova funkcije jetre tijekom 3 tjedna
Patients with moderate or severe renal impairment should be carefully monitored for renal function and adverse reactions.
Kod bolesnica s umjerenim ili teškim oštećenjem funkcije bubrega treba pažljivo motriti funkciju bubrega i nuspojave.
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).
Pri predviđenom medijanu Cmax u stanju dinamičke ravnoteže nakon 600 mg rukapariba dvaput dnevno, predviđeni porast QTcF od početne točke bio je 11,5 msec (90 % CI: 8,77 do 14,2 msec).
The adverse reaction frequency is listed by MedDRA System Organ Class (SOC) at the preferred term level.
System Organ Class, SOC) na razini preporučenog pojma.
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.
Povišene vrijednosti transaminaza u serumu (AST/ALT) Događaji povezani s povišenim vrijednostima alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST) opaženi su u 38 % (svi stupnjevi) i 11 % (≥ CTCAE 3. stupanj) bolesnica.
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.
Srednja dob bila je 61 godina (raspon: od 36 do 85); većina bolesnica bile su bjelkinje (80 %) i sve su imale funkcionalni status prema ECOG-u 0 ili 1.
• medicines to lower blood cholesterol levels- such as rosuvastatin
• lijekove za sniženje razine kolesterola u krvi - kao što je rosuvastatin
Tel: +34 800099526
Tel: +34 800099526 France
CYP1A2 substrates
Supstrati CYP1A2
• For women who are able to become pregnant, a pregnancy test is recommended before starting treatment with Rubraca
• Za žene koje mogu zatrudnjeti, prije liječenja lijekom Rubraca preporučuje se napraviti test na trudnoću.
The clearance ranged from 13.9 to 18.4 L/hour, following a single intravenous dose of rucaparib 12 mg to 40 mg.
SKlirens se kretao u rasponu od 13,9 do 18,4 l/sat, nakon jedne intravenske doze rukapariba od 12 mg do 40 mg.
No dose adjustment is recommended for co-administered medicinal products that are P-gp substrates.
Ne preporučuje se nikakva prilagodba doze za istodobno primjenjivane lijekove koji su supstrati P-gp.
Caution is recommended when rucaparib is co-administered with medicinal products that are strong inhibitors of P-gp.
Preporučuje se oprez prilikom istodobne primjene rukapariba s lijekovima koji su jaki inhibitori P-gp.
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.
Kad se istodobno primjenjuju lijekovi koje metabolizira CYP1A2, osobito lijekovi uskog terapijskog indeksa (npr. tizanidin, teofilin), mogu se razmotriti prilagodbe doze na temelju odgovarajućeg kliničkog praćenja.
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%).
U većini populacije za ocjenu primarnog ishoda djelotvornosti bolesnice su imale: rak osjetljiv na platinu (n=79; 74,5 %); preostale bolesnice su imale rak otporan na platinu (n=20; 18,9 %) ili refraktoran na platinu (n=7; 6,6 %).
None of the patients had received prior treatment with a PARP inhibitor.
Nijedna od bolesnica nije primila prethodnu terapiju inhibitorom PARP-a.
Although in vitro rucaparib metabolism mediated by CYP3A4 was slow, a significant contribution of CYP3A4 in vivo cannot be excluded.
Iako je metabolizam rukapariba in vitro posredovan CYP3A4 bio spor, značajan doprinos CYP3A4 in vivo ne može se isključiti.
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.
In vitro se pokazalo da je rukaparib supstrat P-gp-a i BCRP-a, ali nije supstrat bubrežnog transportera za unos OAT1, OAT3 i OCT2 ili jetrenih transportera OATP1B1 i OATP1B3.
282 days (95% CI [218-335]), and the median overall survival was 18.8 months (95% CI [12.9-NA]).
Medijan preživljenja bez progresije bio je 282 dana (95 % CI [218-335]), a medijan ukupnog preživljenja bio je 18,8 mjeseci (95 % CI [12,9-NP]).
If you are not sure, talk to your doctor, pharmacist or nurse before taking Rubraca.
Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek
Rucaparib is a weak inhibitor of CYP2C8, CYP2D6, and UGT1A1.
Rukaparib je slab inhibitor CYP2C8, CYP2D6 i UGT1A1.
Moreover, according to its mechanism of action, rucaparib may impact human fertility.
Nadalje, na temelju njegovog mehanizma djelovanja, rukaparib može utjecati na plodnost kod ljudi.
Clovis Oncology UK Limited Tel: +44 (0)800 0093361
United Kingdom Clovis Oncology UK Limited Tel: +44 (0)800 0093361
Based on in vitro data, CYP2D6, and to a lesser extent CYP1A2 and CYP3A4, were able to metabolize rucaparib.
Na temelju in vitro podataka, CYP2D6 i u manjoj mjeri CYP1A2 i CYP3A4, mogli su metabolizirati rukaparib.
Rubraca must not be used during breast-feeding.
Lijek Rubraca ne smije se koristiti tijekom dojenja.
Patients with germline (g)BRCA (n=88, 83.0%) or somatic (s)BRCA (n=18, 17.0%) mutations were included.
(n=88; 83,0 %) ili somatskim (s)BRCA (n=18; 17,0 %).
11.1 (8.2, NA) 5.6 (2.9, 2.8)
11,1 (8,2; nije primjenjivo)
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.
Povišene vrijednosti ALT-a opažene su u 34,8 % (svi stupnjevi) i 9,9 % (≥ CTCAE 3. stupanj) bolesnica, povišene vrijednosti AST-a u 31,4 % (svi stupnjevi) i 2,8 % ((≥ CTCAE 3. stupanj) bolesnica, dok su povišene vrijednosti ALT-a i AST-a opažene u 28,6 % (svi stupnjevi) i 2,1 % ((≥ CTCAE 3. stupanj) bolesnica.
• medicines used to cause sleepiness or drowsiness - such as midazolam
• lijekove koji uzrokuju pospanost ili omamljenost - kao što je midazolam
Carcinogenicity studies have not been performed with rucaparib.
Kancerogenost Nisu provedena ispitivanja kancerogenosti s rukaparibom.
Photosensitivity reaction, Rash
Vrlo često reakcije fotoosjetljivosti, osip
• medicines to treat irregular heartbeats - such as digoxin or quinidine
• lijekove za liječenje nepravilnih otkucaja srca - kao što je digoksin ili kinidin
Prior bevacizumab therapy was reported for 22% of patients who received rucaparib and 23% of patients who received placebo.
Prethodna terapija bevacizumabom zabilježena je za 22 % bolesnica koje su primale rukaparib te 23 % bolesnica koje su primale placebo.
The ORR, by independent radiology review for the platinum-sensitive population, was 42/79, 53.2% (95% CI [41.6-64.5]).
ORR, prema neovisnoj radiološkoj ocjeni za populaciju s rakom osjetljivim na platinu, bio je 42/79, 53,2 % (95 % CI [41,6-64,5]).
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.
Ispitivanje ARIEL3 pokazalo je statistički značajno poboljšanje PFS-a u bolesnica koje su randomizirane za primanje rukapariba u odnosu na placebo u ITT populaciji te u podskupinama s
Based on its mechanism of action and preclinical data, rucaparib may cause fetal harm when administered to a pregnant woman.
Na temelju mehanizma djelovanja i nekliničkih podataka, rukaparib može uzrokovati oštećenje fetusa kad se primjenjuje trudnicama.
Rubraca has minor influence on the ability to drive and use machines.
Rubraca malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
• before treatment with Rubraca
• prije liječenja lijekom Rubraca
HRD Groupc
Skupina s HRD-omc
Patients could not have received prior rucaparib or other PARP inhibitor therapy.
Pacijentice nisu mogle ranije primati rukaparib ili drugu terapiju inhibitorom PARP-a.