FrancophonIA/ELRC3.0 huggingface dataset:
English: ARIEL2 population characteristics in 64 patients were: median age 60 years (range 33 to 80), white(75%), ECOG performance status 0 (61%) or 1 (39%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (78%), median time since ovarian cancer diagnosis 53 months [range: 22-197], median progression-free interval from the last platinum treatment 7.6 months [range:
Slovenian: Značilnosti populacije v študiji ARIEL2 z 64 bolnicami so bile: mediana starost 60 let (razpon od 33 do 80), belke (75 %), stanje zmogljivosti po ECOG 0 (61 %) ali 1 (39 %), rak jajčnikov visoke stopnje (100 %), 3 ali več predhodnih ciklov kemoterapije (78 %), mediani čas od diagnoze raka jajčnikov 53 mesecev (razpon: 22-197), mediani interval brez napredovanja bolezni od zadnjega zdravljenja s platino 7,6 meseca (razpon: 0,7-26,5).
English: • For women who are able to become pregnant, a pregnancy test is recommended before starting treatment with Rubraca
Slovenian: - Pri ženskah v rodni dobi se pred uvedbo zdravljenja z zdravilom Rubraca priporoča test nosečnosti.
English: Thrombocytopeniab, Neutropeniab, Febrile neutropenia, Leukopeniab
Slovenian: Pogosti trombocitopenijab, nevtropenijab, febrilna nevtropenija, levkopenijab
English: • medicines used to treat asthma - such as theophylline
Slovenian: • zdravila, ki jih uporabljamo za zdravljenje astme - npr. teofilin.
English: • medicines to treat migraines and headaches - such as dihydroergotamine or ergotamine
Slovenian: • zdravila za zdravljenje migrene in glavobolov - npr. dihidroergotamin ali ergotamin,
English: In order to further confirm the safety and efficacy of rucaparib in the treatment of platinum sensitive, relapsed or progressive, BRCA mutated (germline and/ or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, the MAH should submit the results of study CO-338-043 (ARIEL4), a phase 3, multicentre, open-label, randomised study evaluating the efficacy and safety of rucaparib versus chemotherapy for treatment of relapsed ovarian cancer.
Slovenian: Za nadaljnjo potrditev varnosti in učinkovitosti rukapariba za zdravljenje bolnic z na platino občutljivim, recidivnim ali napredujočim epitelijskim rakom jajčnikov, jajcevodov ali primarnim peritonealnim rakom visoke stopnje, nastalim zaradi mutacij na genu BRCA (germinalnih in/ali somatskih), bo imetnik dovoljenja za promet z zdravilom predložil rezultate študije CO-338-043 (ARIEL4), odprte, multicentrične, randomizirane študije 3.
English: Rubraca 200 mg film-coated tablets Rubraca 250 mg film-coated tablets Rubraca 300 mg film-coated tablets
Slovenian: Rubraca 200 mg filmsko obložene tablete Rubraca 250 mg filmsko obložene tablete Rubraca 300 mg filmsko obložene tablete
English: Effect of P-gp and BCRP inhibitors on rucaparib PK cannot be ruled out.
Slovenian: Učinkov zaviralcev P-gp in BCRP na farmakokinetiko rukapariba ni mogoče izključiti.
English: • Rubraca 300 mg film-coated tablets are yellow, oval, film-coated tablets with “C3” marked on one side.
Slovenian: • Rubraca 300 mg filmsko obložene tablete so rumene, ovalne filmsko obložene tablete z oznako "C3" na eni strani.
English: • Rubraca 200 mg film-coated tablets are blue, round, film-coated tablets with “C2” marked on one side.
Slovenian: • Rubraca 200 mg filmsko obložene tablete so modre, okrogle filmsko obložene tablete z oznako "C2" na eni strani.
English: Rucaparib induced CYP1A2, and down regulated CYP2B6 and CYP3A4 in human hepatocytes at clinically relevant exposures.
Slovenian: Rukaparib je zaviral CYP1A2, in je pri klinično pomembnih izpostavljenostih v človeških human hepatocitih CYP2B6 in CYP3A4 reguliral navzdol.
English: • Do not breast-feed during treatment with Rubraca, and for two weeks after taking the last dose.
Slovenian: Dojenje - Med zdravljenjem z zdravilom Rubraca in še dva tedna po zadnjem odmerku ne smete dojiti.
English: Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinumsensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Slovenian: Zdravilo Rubraca je indicirano kot monoterapija za vzdrževalno zdravljenje odraslih bolnic z na platino občutljivim recidivnim epitelijskim rakom jajčnikov, jajcevodov ali primarnim peritonealnim rakom visoke stopnje, ki se (povsem ali deloma) odziva na kemoterapijo na osnovi platine.
English: Blood samples for 94% (186/196) of the tBRCA patients were evaluated using a central blood germline BRCA (gBRCA) test. Based on these results, 70% (130/186) of the tBRCA patients had a gBRCA mutation and 30% (56/186) had a somatic BRCA mutation.
Slovenian: Na podlagi teh rezultatov je 70 % (130/186) bolnic s tBRCA imelo mutacijo gBRCA, 30 % (56/186) pa jih je imelo somatsko mutacijo BRCA.
English: Moreover, according to its mechanism of action, rucaparib may impact human fertility.
Slovenian: Glede na mehanizem delovanja lahko rukaparib zmanjša plodnost pri človeku.
English: (95% CI)
Slovenian: HR (95-% IZ)
English: Children unde 18 years of age should not be given Rubraca, This medicine has not beem studied in this age group.
Slovenian: Otroci, mlajši od 18 let, ne smejo uporabljati zdravila Rubraca.
English: What you need to know before you take Rubraca Do not take Rubraca:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Rubraca
English: No starting dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Pri bolnicah z blago ali zmerno okvaro ledvic prilagoditev začetnega odmerka ni potrebna (glejte poglavje 5.2).
English: Patients with mild renal impairment (N=149; CLcr between 60 and 89 mL/min, as estimated by the Cockcroft-Gault method) and those with moderate renal impairment (N=76; CLcr between 30 and 59 mL/min) showed approximately 15% and 33% higher steady-state AUC, respectively, compared to patients with normal renal function (N=147; CLcr greater than or equal to 90 mL/min).
Slovenian: Populacijska farmakokinetična analiza je bila opravljena z namenom ocene učinka okvare ledvic na očistek rukapariba pri bolnicah, ki so prejemale rukaparib v odmerku 600 mg dvakrat na dan. Bolnice z blago okvaro ledvic (N = 149; CLcr med 60 in 89 ml/min, ocenjeno z Cockcroft-Gaultovo metodo) in bolnice z zmerno okvaro ledvic (N = 76; CLcr med 30 in 59 ml/min) so imele približno 15 % in 33% višjo vrednost AUC v stanju dinamičnega ravnovesja v primerjavi z bolnicami z normalnim delovanjem ledvic (N = 147; CLcr večji ali enak 90 ml/min).
English: Patients could not have received prior rucaparib or other PARP inhibitor therapy.
Slovenian: Bolnice predhodno niso smele prejemati rukapariba ali drugega zdravljenja z zaviralcem PARP.
English: What Rubraca is used for
Slovenian: Za kaj uporabljamo zdravilo Rubraca
English: Enzymes responsible for rucaparib metabolism have not been identified.
Slovenian: Encimov, ki so odgovorni za presnavljanje rukapariba, še niso prepoznali.
English: In vitro, rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Slovenian: In vitro je rukaparib je močan zaviralec MATE1 in MATE2-K, zmeren zaviralec OCT1 in šibek zaviralec OCT2.
English: 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.
Slovenian: V študijah toksičnosti s ponavljajočimi peroralnimi odmerki rukapariba niso opazili učinkov na srce pri vrednosti Cmax rukapariba, primerljivi z vrednostjo pri bolnicah.
English: Rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Slovenian: Rukaparib je močan zaviralec MATE1 in MATE2-K, zmeren zaviralec OCT1 in šibek zaviralec OCT2.
English: Myelodysplastic syndrome / Acute myeloid leukaemia
Slovenian: Mielodisplastični sindrom/akutna mieloična levkemija
English: In the tBRCA population, 31% of patients (40/130) in the rucaparib group and 35% of patients (23/66) in the placebo group had measurable disease at baseline.
Slovenian: V populaciji tBRCA je 31 % bolnic (40/130) v skupini, ki je prejemala rukaparib, in 35 % bolnic
English: Embryofetal toxicity
Slovenian: Embrio-fetalna toksičnost
English: Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome, Erythema
Slovenian: Pogosti makulopapulozni izpuščaj, sindrom palmarno-plantarne eritrodisestezije, eritem
English: • Rubraca 250 mg film-coated tablets are white, diamond-shaped, film-coated tablets with “C25” marked on one side.
Slovenian: • Rubraca 250 mg filmsko obložene tablete so bele filmsko obložene tablete v obliki romba z oznako "C25" na eni strani.
English: There is no specific treatment in the event of Rubraca overdose, and symptoms of overdose are not established.
Slovenian: Specifičnega zdravljenja za preveliko odmerjanje zdravila Rubraca ni.
English: In patients with moderate renal impairment (CLcr of 30-59 mL/min), frequencies of some adverse reactions increased: Grade 3 or 4 anaemia (31%), Grade 3 or 4 thrombocytopenia (12%), and Grade 3 fatigue/asthenia (15%) were higher than in patients with mild renal impairment (CLcr > 59-80 mL/min) or normal renal function (CLcr > 80 mL/min) (21%, 5%, and 8%).
Slovenian: Pri bolnicah z zmerno ledvično okvaro (vrednost CLcr 30-59 ml/min) so bile pogostnosti nekaterih neželenih učinkov večje: anemija 3. ali 4. stopnje (31 %), trombocitopenija 3. ali 4. stopnje (12 %) in utrujenost/astenija 3. stopnje (15 %) so bile pogostejše kot pri bolnicah z blago ledvično okvaro
English: No starting dose adjustment is required in patients with mild hepatic impairment (see section 5.2).
Slovenian: Pri bolnicah z blago okvaro jeter prilagoditev začetnega odmerka ni potrebna (glejte poglavje 5.2).
English: Rucaparib increased midazolam Cmax by 1.13 fold (90% CI: 0.95 to 1.36) and AUCinf by 1.38 fold (90% CI: 1.13 to 1.69).
Slovenian: Rukaparib je povišal Cmax midazolama za 1,13-krat (90-odstotni IZ: 0,95 do 1,36,) AUCinf pa za 1,38krat (90-odstotni IZ: 1,13 do 1,69).
English: Rucaparib increased S-warfarin Cmax by 1.05 fold (90% CI: 0.99 to 1.12) and AUC0-96h by 1.49 fold (90% CI: 1.40 to 1.58), respectively.
Slovenian: Rukaparib je povišal Cmax S-varfarina za 1,05-krat (90-odstotni IZ: 0,99 do 1,12), AUC0-96 h pa za 1,49-krat (90-odstotni IZ: 1,40 do 1,58).
English: Rucaparib increased omeprazole Cmax by 1.09 fold (90% CI: 0.93 to 1.27) and AUCinf by 1.55 fold (90% CI: 1.32 to 1.83).
Slovenian: Rukaparib je povišal Cmax omeprazola za 1,09-krat (90-odstotni IZ: 0,93 do 1,27), AUCinf pa za 1,55krat (90-odstotni IZ: 1,32 do 1,83).
English: Blue, 11 mm, round film-coated tablet, debossed with “C2”.
Slovenian: Modra, okrogla filmsko obložena tableta premera 11 mm z oznako "C2".
English: There are no animal studies on the excretion of rucaparib in breast milk.
Slovenian: Študij na živalih o izločanju rukapariba v mleko ni. Ni znano, ali se rukaparib in/ali njegovi presnovki izločajo v materino mleko.
English: Thus, the risk for clinically significant QTcF increase from baseline (i.e. > 20 msec) is low.
Slovenian: Zato je tveganje za klinično pomembno podaljšanje intervala QTcF od izhodišča (t.j.
English: Dysgeusia, Dizziness
Slovenian: Občasni disgevzija, omotica
English: No dose adjustment is recommended for co-administered medicinal products that are P-gp substrates.
Slovenian: Za sočasna zdravila, ki so substrati P-gp, prilagajanje odmerka ni priporočeno.
English: Median overall survival - months (95% CI)
Slovenian: Mediano celokupno preživetje meseci (95-% IZ) Cenzorirano N (%)
English: No formal studies of rucaparib in patients with renal impairment have been conducted.
Slovenian: Formalnih študij z rukaparibom pri bolnicah z motnjami v delovanju ledvic niso izvedli.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving rucaparib.
Slovenian: Bolnicam v rodni dobi je treba odsvetovati nosečnost v obdobju, ko prejemajo rukaparib.
English: Hepatobiliary disorders Very common
Slovenian: Zelo pogosti anemijab
English: Grade 3 without other signs of liver dysfunction Monitor LFTs weekly until resolution to Grade ≤ 2
Slovenian: Stopnja 3 brez drugih znakov nepravilnega delovanja jeter
English: Missed doses If a dose is missed, the patient should resume taking Rubraca with the next scheduled dose.
Slovenian: Če bolnica izpusti odmerek zdravila Rubraca, mora vzeti naslednji odmerek ob običajnem času.
English: White, 11 x 15 mm, diamond-shaped film-coated tablet, debossed with “C25”.
Slovenian: Bela filmsko obložena tableta v obliki romba velikosti 11 x 15 mm z oznako "C25".
English: Hepatic impairment No formal studies of rucaparib in patients with hepatic impairment have been conducted.
Slovenian: Formalnih študij z rukaparibom pri bolnicah z motnjami v delovanju jeter niso izvedli.
English: Fertility studies have not been conducted with rucaparib.
Slovenian: Študij plodnosti z rukaparibom niso opravili.
English: • Rubraca is not recommended during pregnancy.
Slovenian: - Uporaba zdravila Rubraca med nosečnostjo ni priporočljiva.
English: Clovis Oncology UK Limited Tel: +44 (0)800 0093361
Slovenian: Tel: +44 (0)800 0093361
English: In the ITT population, 38% of patients (141/375) in the rucaparib group and 35% of patients (66/189) in the placebo group had measurable disease at baseline.
Slovenian: V populaciji ITT je 38 % bolnic (141/375) v skupini, ki je prejemala rukaparib, in 35 % bolnic
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Hematološka toksičnost
English: vomiting, anaemia, abdominal pain, dysgeusia, ALT elevations, AST elevations, decreased appetite, diarrhoea, thrombocytopenia and creatinine elevations.
Slovenian: Neželeni učinki, ki so se pojavili pri ≥ 20 % bolnic, ki so prejemale rukaparib, so bili navzea, utrujenost/astenija, bruhanje, anemija, bolečine v trebuhu, disgevzija, zvišanje ravni ALT, zvišanje ravni AST, zmanjšanje teka, driska, trombocitopenija in zvišanje ravni kreatinina.
English: Clovis Oncology France SAS Tel: +31 (0)8000227859
Slovenian: Tel: +31 (0)8000227859
English: Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
English: Rubraca 250 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 250 mg of rucaparib.
Slovenian: Rubraca 250 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje rukaparibijev kamsilat v količini 250 mg rukapariba.
English: Population PK analysis suggested that concomitant use of PPIs is unlikely to have clinically meaningful impact on rucaparib PK. A firm conclusion cannot be made regarding the effect of co-administration of rucaparib and PPIs because dose level and time of administration have not been documented in detail for the PPIs.
Slovenian: Dokončne ugotovitve o učinku sočasnega dajanja rukapariba in zaviralcev protonske črpalke ni mogoče podati, saj ravni odmerka in časa dajanja zaviralcev protonske črpalke niso podrobno dokumentirali.
English: There is no requirement for BRCA testing prior to using Rubraca for the maintenance treatment of adult patients with relapsed high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) who are in a complete or partial response to platinum-based chemotherapy.
Slovenian: Pred uporabo zdravila Rubraca za vzdrževalno zdravljenje odraslih bolnic z recidivnim epitelijskim rakom jajčnikov (EOC - epithelial ovarian cancer), jajcevodov (FTC - fallopian tube cancer) ali primarnim peritonealnim rakom (PPC - primary peritoneal cancer) visoke stopnje, ki se povsem ali deloma odzivajo na kemoterapijo na osnovi platine, ni potrebno testiranje za mutacijo BRCA.
English: Rubraca 300 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 300 mg of rucaparib.
Slovenian: Rubraca 300 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje rukaparibijev kamsilat v količini 300 mg rukapariba.
English: Prior bevacizumab therapy was reported for 22% of patients who received rucaparib and 23% of patients who received placebo.
Slovenian: in pri 23 % bolnic, ki so prejemale placebo, so poročali o predhodnem zdravljenju z bevacizumabom.
English: Management
Slovenian: Uravnavanje
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain
Slovenian: Zelo pogosti navzea, bruhanje, driska, dispepsija, bolečine v trebuhu
English: Photosensitivity reaction, Rash, Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome
Slovenian: izpuščaj, makulopapulozni izpuščaj, sindrom palmarnoplantarne eritrodisestezije
English: Rubraca 200 mg film-coated tablets: Each film-coated tablet contains rucaparib camsylate corresponding to 200 mg of rucaparib.
Slovenian: Rubraca 200 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje rukaparibijev kamsilat v količini, ki ustreza 200 mg rukapariba.
English: The clearance ranged from 13.9 to 18.4 L/hour, following a single intravenous dose of rucaparib 12 mg to 40 mg.
Slovenian: MOčistek je po enkratnem intravenskem odmerku rukapariba od 12 mg do 40 mg znašal od 13,9 do 18,4 l/uro.
English: Dysgeusia, Dizziness,
Slovenian: Zelo pogosti disgevzija, omotica
English: - Rubraca 300 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), and iron oxide yellow (E172).
Slovenian: Rubraca 300 mg filmsko obložene tablete polivinilalkohol (E1203), titanov dioksid (E171), makrogol 4000 (E1521), smukec (E553b) in rumeni železov oksid (E172).
English: Tablet coating Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 (E1521)
Slovenian: Obloga tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol 4000 (E1521) smukec (E553b)
English: - Rubraca 250 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), and talc (E553b)
Slovenian: Rubraca 250 mg filmsko obložene tablete polivinilalkohol (E1203), titanov dioksid (E171), makrogol 4000 (E1521) in smukec (E553b).
English: Rubraca 300 mg film-coated tablets rucaparib This medicine is subject to additional monitoring.
Slovenian: Rubraca 200 mg filmsko obložene tablete Rubraca 250 mg filmsko obložene tablete Rubraca 300 mg filmsko obložene tablete rukaparib Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Anaemiab, Thrombocytopeniab, Neutropeniab
Slovenian: Zelo pogosti anemijab, trombocitopenijab, nevtropenijab,
English: How to take Rubraca
Slovenian: Kako jemati zdravilo Rubraca
English: Fatiguec
Slovenian: Rukaparib
English: You may get sunburn more easily during treatment with Rubraca.
Slovenian: Med zdravljenjem z zdravilom Rubraca lahko hitreje dobite sončne opekline.
English: • Tablet coating: - Rubraca 200 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133) and indigo carmine aluminium lake (E132).
Slovenian: Rubraca 200 mg filmsko obložene tablete polivinilalkohol (E1203), titanov dioksid (E171), makrogol 4000 (E1521), smukec (E553b), briljantno modro FCF (E133) in indigotin (E132).
English: 500 mg twice daily (two 250 mg tablets twice daily)
Slovenian: 600 mg dvakrat na dan (dve 300-miligramski tableti dvakrat na dan) Prvo zmanjšanje odmerka 500 mg dvakrat na dan (dve 250-miligramski tableti dvakrat na dan) Drugo zmanjšanje odmerka 400 mg dvakrat na dan (dve 200-miligramski tableti dvakrat na dan) Tretje zmanjšanje odmerka 300 mg dvakrat na dan (ena 300-miligramska tableta dvakrat na dan)
English: • rash
Slovenian: LOH
English: • red patches on the skin
Slovenian: - rdeče lise na koži Poročanje o neželenih učinkih
English: Adverse reactions occurring in ≥ 20% of patients receiving rucaparib were nausea, fatigue/asthenia,
Slovenian: Pri 22 % bolnic, ki so prejemale rukaparib,
English: Clovis Oncology Germany GmbH Tel: +49 (0)8005892665
Slovenian: Tel: +49 (0)8005892665
English: Each tablet contains rucaparib camsylate corresponding to 250 mg rucaparib.
Slovenian: Ena tableta vsebuje rukaparibijev kamsilat v količini, ki ustreza 250 mg rukapariba.
English: Each tablet contains rucaparib camsylate corresponding to 300 mg rucaparib.
Slovenian: Ena tableta vsebuje rukaparibijev kamsilat v količini, ki ustreza 300 mg rukapariba.
English: Contraception
Slovenian: ZDRAVILA
English: Each tablet contains rucaparib camsylate corresponding to 200 mg rucaparib.
Slovenian: Ena tableta vsebuje rukaparibijev kamsilat v količini, ki ustreza 200 mg rukapariba.
English: Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube,
Slovenian: Zdravilo Rubraca je indicirano kot monoterapija za zdravljenje odraslih bolnic z na platino občutljivim, recidivnim ali napredujočim epitelijskim rakom jajčnikov, jajcevodov ali primarnim peritonealnim rakom visoke stopnje, nastalim zaradi mutacij na genu BRCA (germinalnih in/ali somatskih), in ki so že prejele dva ali več ciklov kemoterapije na osnovi platine in ki ne morejo prenašati nadaljnjega zdravljenja s kemoterapijo na osnovi platine.
English: Rubraca 300 mg film-coated tablets
Slovenian: Rubraca 300 mg filmsko obložena tableta
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: NALEPKA NA STEKLENIČKI
English: ITT populationa
Slovenian: Populacija ITTa
English: Rubraca 250 mg film-coated tablets
Slovenian: Rubraca 250 mg filmsko obložena tableta
English: Rubraca 200 mg film-coated tablets
Slovenian: Rubraca 200 mg filmsko obložena tableta
English: Clovis Oncology Ireland Limited Tel: +353 16950030
Slovenian: Tel: +353 16950030
English: Rubraca 300 mg film-coated tablets rucaparib
Slovenian: Rubraca 300 mg filmsko obložene tablete rukaparib
English: Clovis Oncology Germany GmbH Tel: +43 (0)800005924
Slovenian: Tel: +43 (0)800005924
English: Nausea, Vomiting, Diarrhoea, Abdominal pain
Slovenian: Pogosti navzea, bruhanje, driska, bolečine v trebuhu
English: Caution is recommended when rucaparib is co-administered with medicinal products that are strong inhibitors of P-gp.
Slovenian: Pri sočasni uporabi rukapariba in zdravil, ki so močni zaviralci P-gp, je priporočljiva previdnost.
English: Rubraca 250 mg film-coated tablets rucaparib
Slovenian: Rubraca 250 mg filmsko obložene tablete rukaparib
English: Rubraca contains the active substance rucaparib.
Slovenian: Zdravilo Rubraca vsebuje učinkovino rukaparib.
English: Rubraca 200 mg film-coated tablets rucaparib
Slovenian: Rubraca 200 mg filmsko obložene tablete rukaparib
English: Elderly
Slovenian: - srbečica
English: General toxicology
Slovenian: Splošna toksičnost
English: Patients who had been hospitalised for bowel obstruction in the last 3 months were excluded.
Slovenian: bolnic je prejemalo rukaparib v odmerku 600 mg dvakrat na dan. Bolnice, ki so bile hospitalizirane zaradi obstrukcije črevesja v 3 mesecih pred začetkom zdravljenja, so bile izključene.
English: Median progression-free survival - days (95% CI)
Slovenian: Mediano preživetje brez poslabšanja bolezni v dnevih (95odstotni IZ)
English: Maintenance treatment of recurrent ovarian cancer
Slovenian: Delež bolnic z rakom,
English: • diarrhoea
Slovenian: Bolezni živčevja
English: Dyspnoea
Slovenian: Placebo
English: Photosensitivity has been observed in patients treated with rucaparib.
Slovenian: Pri bolnicah, zdravljenih z rukaparibom, so opazili preobčutljivost na svetlobo.
English: In terms of safety, the side effects were considered acceptable and manageable with appropriate measures.
Slovenian: Z vidika varnosti se neželeni učinki štejejo za sprejemljive in jih je mogoče obvladati z ustreznimi ukrepi.
English: What measures are being taken to ensure the safe and effective use of Cotellic?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cotellic?