natgillin/translations-raw huggingface dataset:
In studies 312-0116/0117 and 312-0119, rash (reported as dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule and skin plaque) occurred in 31.1% of subjects who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 8.2% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab).
U ispitivanjima 312-0116/0117 i 312-0119, osip (zabilježen kao generalizirani eksfolijativni dermatitis, izbijanje kožnih promjena uzrokovano lijekom, osip, eritematozni osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip, pruritični osip, pustularni osip, vezikularni osip, papula i plak na koži) se pojavio u 31,1% ispitanika koji su primali idelalisib + anti-CD20 monoklonsko protutijelo (rituksimab ili ofatumumab) i 8,2% onih koji su primali samo anti-CD20 monoklonsko protutijelo (rituksimab ili ofatumumab).
Tell your doctor right away if you become ill (especially with a fever, cough or breathing difficulties) while you are taking Zydelig.
Ako se razbolite (osobito ako Vam se javi vrućica, kašalj ili otežano disanje) dok uzimate Zydelig, odmah o tome obavijestite liječnika.
Blood tests may also show: • increased blood levels of fats
Pretrage krvi također mogu pokazati: • povišene razine masnoća u krvi
The recommended dose is 150 mg idelalisib twice daily.
Preporučena doza je 150 mg idelalisiba dva puta dnevno.
• quetiapine, a medicine used to treat schizophrenia, bipolar disorder and major depressive disorder
• kvetiapin, lijek koji se primjenjuje za liječenje shizofrenije, bipolarnog poremećaja i velikog depresivnog poremećaja
Breast-feeding It is not known whether idelalisib and its metabolites are excreted in human milk.
Dojenje Nije poznato izlučuju li se idelalisib i njegovi metaboliti u majčino mlijeko.
Idelalisib in combination with ofatumumab
Idelalisib u kombinaciji s ofatumumabom
If you miss a dose by less than 6 hours, take the missed dose right away.
Ako propustite uzeti dozu i sjetite se za manje od 6 sati, odmah uzmite propuštenu dozu.
In an embryo-foetal development study in rats, increased post-implantation loss, malformations (absence of caudal vertebrae and in some cases also of sacral vertebrae), skeletal variations and lower foetal body weights were observed.
U ispitivanju embriofetalnog razvoja na štakorima zabilježeni su povećan postimplantacijski gubitak, malformacije (nedostatak kaudalnih, a u nekim slučajevima i sakralnih kralješaka), razlike u razvoju kostura i smanjena tjelesna težina fetusa.
CYP3A inducers
CYP3A induktori
Blistering can also involve the lining of the mouth, genitals, and/or eyes.
Mjehuri također mogu zahvatiti sluznicu usta, spolnih organa i/ili očiju.
Increases in liver transaminases were generally observed within the first 12 weeks of treatment, and were reversible with dose interruption (see section 4.2).
Povećanja vrijednosti jetrenih transaminaza uglavnom su uočena unutar prvih 12 tjedana liječenja, te su bila reverzibilna ako se prekinulo uzimanje (vidjeti dio 4.2).
Serum transaminase elevations correlated with hepatic necrosis in dogs, but were not observed in rats.
Porast transaminaza u serumu bio je povezan s nekrozom jetre u pasa, ali nije uočen u štakora.
The safety and efficacy of idelalisib were assessed in a single-arm, multicentre clinical study (study 101-09) conducted in 125 subjects with indolent B-cell non-Hodgkin lymphoma (iNHL, including: FL, n = 72; SLL, n = 28; lymphoplasmacytic lymphoma/Waldenström macroglobulinaemia [LPL/WM], n = 10; and marginal zone lymphoma [MZL], n = 15).
Sigurnost i djelotvornost idelalisiba procijenjena je multicentričnim kliničkim ispitivanjem na jednoj skupini (ispitivanje 101-09) provedenim na 125 ispitanika s indolentnim B-staničnim nonHodgkinovim limfomom (iNHL, uključujući FL, n = 72; SLL, n = 28; limfoplazmocitni limfom/Waldenströmova makroglobulinemija [LPL/WM], n = 10 i limfom marginalne zone [engl. marginal zone lymphoma, MZL], n = 15).
Treatment with Zydelig should be conducted by a physician experienced in the use of anti-cancer therapies.
Liječenje Zydeligom treba provoditi liječnik s iskustvom u primjeni antitumorske terapije.
• ciclosporin, sirolimus, tacrolimus, medicines used to control your body's immune response after a transplant
• ciklosporin, sirolimus, takrolimus, lijekovi koji se primjenjuju za kontrolu imunološkog odgovora nakon transplantacije
Idelalisib did not induce mutations in the microbial mutagenesis (Ames) assay, was not clastogenic in the in vitro chromosome aberration assay using human peripheral blood lymphocytes, and was not genotoxic in the in vivo rat micronucleus study.
Idelalisib nije uzrokovao mutacije u ispitivanjima mutagenosti na bakterijama (Amesov test), nije pokazao klastogena svojstva u in vitro ispitivanju kromosomskih aberacija na humanim limfocitima iz periferne krvi niti je pokazao genotoksičnost u in vivo mikronukleus testu na štakorima.
Expected effect of idelalisib on drug levels
Očekivani učinak idelalisiba na razine lijeka
Co-administration of idelalisib with CYP3A substrates may increase their systemic exposures and increase or prolong their therapeutic activity and adverse reactions.
Istovremena primjena idelalisiba s CYP3A supstratima može povećati sistemsku izloženost takvim tvarima i pojačati ili produljiti njihovo terapijsko djelovanje i nuspojave.
There have also been reports of hepatocellular injury including hepatic failure.
Također su zabilježena hepatocelularna oštećenja uključujući zatajenje jetre.
Buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem
Buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem
Rash was generally mild to moderate and resulted in discontinuation of treatment in 2.1% of subjects.
Osip je uglavnom bio blag do umjeren i doveo je do prekida liječenja u 2,1% ispitanika.
Clinical monitoring is recommended.
Preporučuje se kliničko praćenje.
If Grade 2 or higher elevations in ALT and/or AST are observed, patients' ALT, AST, and total bilirubin must be monitored weekly until the values return to Grade 1 or below.
Ako se uoči povišenje vrijednosti ALT i/ili AST 2. stupnja ili više, nužan je tjedni nadzor vrijednosti ALT/AST i ukupnog bilirubina bolesnika sve dok se vrijednosti ne spuste na 1. stupanj ili niže.
The idelalisib AUC (unbound), after accounting for differences in protein binding, was ~80% (1.8-fold) higher in moderate and ~152% (2.5-fold) higher in severe impairment compared to matched controls.
AUC idelalisiba (nevezanog), nakon što su se uračunale razlike u vezanju za proteine, bio je ~80% (1,8 puta) viši u ispitanika s umjerenim i ~152% (2,5 puta) viši u ispitanika s teškim oštećenjem u usporedbi s odgovarajućim kontrolnim ispitanicima.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON LABEL
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU OZNAČIVANJE KUTIJE
The analyses of PFS, overall response rate (ORR) and lymph node response rate (LNR) were based on evaluation by an independent review committee (IRC).
Analize PFS-a, ukupne stope odgovora (ORR, overall response rate) i stope odgovora limfnih čvorova (LNR, lymph node response rate) temeljene su na procjeni neovisnog stručnog povjerenstva (IRC, independent review committee).
Subjects received 150 mg of idelalisib orally twice daily until evidence of disease progression or unacceptable toxicity.
Ispitanici su primali 150 mg idelalisiba peroralno dva puta dnevno do progresije bolesti ili neprihvatljive toksičnosti.
Subjects had a median Cumulative Illness Rating Scale (CIRS) score of 8.
Medijan bodova na ljestvici za procjenu kumulativnog učinka bolesti (CIRS) u ispitanika bio je 8.
Only subjects that had both baseline and ≥ 1 evaluable post-baseline assessments were included in this analysis.
U analizu su uključeni samo ispitanici koji su bili procjenjivi i na početnoj procjeni i na ≥ 1 procjeni nakon početne.
Women should avoid becoming pregnant while taking Zydelig, and for up to 1 month after ending treatment.
Žene trebaju izbjegavati trudnoću dok uzimaju Zydelig i još mjesec dana nakon završetka liječenja.
GASTROINTESTINAL MOTILITY AGENTS
LIJEKOVI ZA GASTROINTESTINALNI MOTILITET Cisaprid
Tell your doctor right away at the first sign of diarrhoea.
Obavijestite svog liječnika čim se pojavi prvi znak proljeva.
In a rat male fertility study, decreases in epididymides and testes weight were observed but no adverse effects on mating or fertility parameters, and no degeneration or loss in spermatogenesis were observed.
U ispitivanju plodnosti na mužjacima štakora zabilježeno je smanjenje težine epididimisa i testisa, ali štetni učinci na parenje ili pokazatelje plodnosti, degeneracije ili gubitak spermatogeneze nisu zabilježeni.
Zydelig contains sunset yellow FCF which may cause allergic reactions.
Zydelig sadrži boju sunset yellow FCF koja može uzrokovati alergijske reakcije.
No hepatic impairment or chronic transaminase elevations were observed in rats or dogs in studies of 13 weeks and longer duration.
Ni oštećenje funkcije jetre niti dugotrajno povišenje transaminaza nije uočeno u štakora ili pasa u ispitivanjima u trajanju od 13 tjedana i duže.
↑ serum concentrations Dose reductions of colchicine may be required.
↑ koncentracije u serumu Može biti potrebno smanjiti dozu kolhicina.
Table 2: Adverse drug reactions reported in clinical studies in subjects with haematologic malignancies receiving idelalisib
Tablica 2: Nuspojave zabilježene u kliničkim ispitivanjima u ispitanika s hematološkim zloćudnim bolestima koji su primali idelalisib
Stevens-Johnson syndrome and toxic epidermal necrolysis Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with fatal outcomes have been reported when idelalisib was administered concomitantly with other medicinal products associated with these syndromes.
Stevens-Johnsonov sindrom i toksična epidermalna nekroliza Zabilježeni su slučajevi Stevens-Johnsonovog sindroma (SJS) i toksične epidermalne nekrolize (TEN) sa smrtnim ishodima kada se idelalisib primjenjivao istovremeno s drugim lijekovima koji su povezani s tim sindromima.
Caution should be exercised, including consideration of dose reduction, when co-administering tadalafil with idelalisib.
Potreban je oprez, uključujući razmatranje sniženja doze, kad se tadalafil primjenjuje istovremeno s idelalisibom.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU OZNAČIVANJE BOCE
Subjects were randomised 2:1 to receive idelalisib 150 mg twice daily and 12 infusions of ofatumumab over 24 weeks, or 12 infusions of ofatumumab only over 24 weeks.
Ispitanici su bili randomizirani u omjeru 2:1 kako bi primili idelalisib u dozi od 150 mg dva puta dnevno i 12 infuzija ofatumumaba tijekom 24 tjedna ili samo 12 infuzija ofatumumaba tijekom 24 tjedna.
↑ serum concentrations Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
↑ koncentracije u serumu Preporučuje se pažljivi nadzor zbog nuspojava (npr., respiratorna depresija, sedacija).
• clarithromycin, telithromycin, medicines used to treat bacterial infections
• klaritromicin, telitromicin, lijekovi koji se primjenjuju za liječenje bakterijskih infekcija
Of these, 5.7% who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 1.5% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab) had rash of Grade 3, and no subjects had an adverse reaction of Grade 4.
Od toga, u 5,7% ispitanika koji su primali idelalisib + antiCD20 monoklonsko protutijelo (rituksimab ili ofatumumab) i 1,5% ispitanika koji su primali samo anti-CD20 monoklonsko protutijelo (rituksimab ili ofatumumab) pojavio se osip 3. stupnja, a ni u jednog ispitanika nije se pojavila nuspojava 4. stupnja.
Common * Comprised of opportunistic infections as well as bacterial and viral infections such as pneumonia, bronchitis, and sepsis.
* Obuhvaćaju oportunističke infekcije kao i bakterijske i virusne infekcije poput pneumonije, bronhitisa i sepse.
In patients who resumed idelalisib at a lower dose, 26% had recurrence of ALT/AST elevation.
U 26% bolesnika koji su nastavili liječenje idelalisibom u nižoj dozi, došlo je do ponovnog povišenja vrijednosti ALT/AST.
Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) Rarely, cases of SJS and TEN have occurred when idelalisib was administered concomitantly with other medicinal products associated with these syndromes (bendamustine, rituximab, allopurinol, and amoxicillin).
Stevens-Johnsonov sindrom i toksična epidermalna nekroliza (vidjeti dio 4.4) Rijetko su se javili slučajevi SJS-a i TEN-a kada se idelalisib primjenjivao istovremeno s drugim lijekovima koji su povezani s tim sindromima (bendamustinom, rituksimabom, alopurinolom i amoksicilinom).
↑ serum concentrations Concurrent administration of salmeterol and idelalisib is not recommended.
Ne preporučuje se istovremena primjena salmeterola i idelalisiba.
You should take additional medicine provided by your doctor while you are taking Zydelig to prevent one type of infection.
Dok uzimate Zydelig, morate dodatno uzimati lijek koji će Vam dati liječnik za sprječavanje jedne vrste infekcije.
Regular clinical and laboratory monitoring for CMV infection is recommended in patients with positive CMV serology at the start of treatment with idelalisib or with other evidence of a history of CMV infection.
Preporučuje se redovito kliničko i laboratorijsko praćenje zbog moguće pojave infekcije CMV-om u bolesnika s pozitivnim serološkim nalazom na CMV na početku liječenja idelalisibom ili s drugim dokazom ranije infekcije CMV-om.
If you miss a dose by more than 6 hours, wait and take the next dose at your usual time.
Ako je prošlo više od 6 sati od propuštene doze, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
A study of pharmacokinetics and safety of idelalisib was performed in healthy subjects and subjects with severe renal impairment (estimated CrCl 15 to 29 mL/min).
Ispitivanje farmakokinetike i sigurnosti idelalisiba provedeno je na zdravim ispitanicima i ispitanicima s teškim oštećenjem funkcije bubrega (procijenjen CrCl 15-29 ml/min).
Paediatric population The pharmacokinetics of idelalisib in paediatric subjects has not been established (see section 4.2).
Farmakokinetika idelalisiba u pedijatrijskih ispitanika nije ustanovljena (vidjeti dio 4.2).
Upon initiation of idelalisib, a temporary increase in lymphocyte counts (i.e., ≥ 50% increase from baseline and above absolute lymphocyte count of 5,000/mcL) has been observed.
Pri uvođenju idelalisiba opaženo je privremeno povećanje broja limfocita (tj. povećanje od ≥ 50% u odnosu na početnu vrijednost i iznad apsolutnog broja limfocita od 5000/µl).
Treatment with Zydelig should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm3.
Liječenje Zydeligom treba prekinuti sve dok je u bolesnika apsolutni broj neutrofila (ABN) manji od 500 po mm3.
↑ serum concentrations Caution should be exercised and patients closely observed for bosentan-related toxicity.
↑ koncentracije u serumu Potreban je oprez i pažljivo promatranje bolesnika zbog toksičnosti povezane s bosentanom.
Idelalisib is a selective inhibitor of adenosine-5'-triphosphate (ATP) binding to the catalytic domain of PI3Kδ, resulting in inhibition of the phosphorylation of the key lipid second messenger phosphatidylinositol and prevention of Akt (protein kinase B) phosphorylation.
Idelalisib je selektivni inhibitor vezanja adenozin-5'-trifosfata (ATP-a) na katalitičku domenu PI3Kδ, čime se inhibira fosforilacija fosfatidil-inozitola, ključnog lipidnog drugog glasnika, i sprečava fosforilacija kinaze Akt (protein kinaze B).
Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Zydelig je indiciran u kombinaciji s rituksimabom za liječenje odraslih bolesnika s kroničnom limfocitnom leukemijom (KLL):
Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive in B-cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow.
Idelalisib inhibira fosfatidil-inozitol-3-kinazu p110δ (PI3Kδ), koja je pretjerano aktivna u zloćudnim bolestima B-stanica i ključna u brojnim signalnim putevima koji pokreću proliferaciju, preživljavanje, naseljavanje i zadržavanje zloćudnih stanica u limfnom tkivu i koštanoj srži.
Patients with CMV viraemia without associated clinical signs of CMV infection should be carefully monitored.
Potrebno je pažljivo nadzirati bolesnike s CMV viremijom bez povezanih kliničkih znakova infekcije CMV-om.
A study of pharmacokinetics and safety of idelalisib was performed in healthy subjects and subjects with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Ispitivanje farmakokinetike i sigurnosti idelalisiba provedeno je na zdravim ispitanicima i ispitanicima s umjerenim (Child-Pugh stadij B) ili teškim (Child-Pugh stadij C) oštećenjem funkcije jetre.
Maintain Zydelig dosing.
Održite doziranje Zydeliga.
Co-administration of multiple doses of idelalisib 150 mg twice daily to healthy subjects resulted in comparable exposures for rosuvastatin (AUC 90% CI: 87, 121) and digoxin (AUC 90% CI: 98, 111), suggesting no clinically relevant inhibition of BCRP, OATP1B1/1B3 or systemic P-gp by idelalisib.
Istovremena primjena višestrukih doza idelalisiba od 150 mg dva puta dnevno u zdravih ispitanika dovela je do izloženosti rosuvastatinu (AUC 90% CI: 87; 121) usporedive s izloženošću digoksinu (AUC 90% CI: 98; 111), što ukazuje na to da idelalisib nije klinički značajan inhibitor BCRP, OATP1B1/1B3 ili sistemskog P-gp.
Stevens-Johnson syndrome/ toxic epidermal necrolysis
Stevens-Johnsonov sindrom / toksična epidermalna nekroliza rijetko rijetko
ANC 1,000 to < 1,500/mm3
ABN 1000 do < 1500/mm3
• alfuzosin, a medicine used to treat an enlarged prostate • dabigatran, warfarin, medicines used to thin the blood
• alfuzosin, lijek koji se primjenjuje za liječenje povećane prostate • dabigatran, varfarin, lijekovi koji se primjenjuju za razrjeđivanje krvi
GS-563117 is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or UGT1A1, or of the transporters P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, or OCT2.
GS-563117 nije inhibitor metaboličkih enzima CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili UGT1A1 ili prijenosnika P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 ili OCT2.
Through inhibition of chemokine receptors CXCR4 and CXCR5 signalling induced by the chemokines CXCL12 and CXCL13, respectively, idelalisib inhibits homing and retention of malignant B-cells in the tumour microenvironment including lymphoid tissues and the bone marrow.
Inhibicijom signalizacije preko receptora za kemokine CXCR4 i CXCR5 koje induciraju kemokini CXCL12 odnosno CXCL13, idelalisib inhibira naseljavanje i zadržavanje zloćudnih B-stanica u mikrookolinu tumora, uključujući limfno tkivo i koštanu srž.
When idelalisib is co-administered with other medicinal products, the Summary of Product Characteristics (SmPC) for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors.
Kad se idelalisib istovremeno primjenjuje s drugim lijekovima, potrebno je pročitati sažetke opisa svojstava (SPC) drugih lijekova zbog preporuka za istovremenu primjenu s CYP3A4 inhibitorima.
Idelalisib exposure may be reduced when co-administered with CYP3A inducers such as rifampicin, phenytoin, St. John's wort (Hypericum perforatum), or carbamazepine.
Izloženost idelalisibu može biti smanjena ako se primjenjuje istovremeno s CYP3A induktorima kao što su rifampicin, fenitoin, gospina trava (Hypericum perforatum) ili karbamazepin.
PHOSPHODIESTERASE INHIBITORS
INHIBITORI FOSFODIESTERAZE
Once pneumonitis has resolved and if re-treatment is appropriate, resumption of treatment at 100 mg twice daily can be considered.
Kada se pneumonitis povuče i ako bude prikladno ponoviti liječenje, može se razmotriti nastavak liječenja dozom od 100 mg dva puta dnevno.
If the patient misses a dose of Zydelig within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal dosing schedule.
Ako bolesnik propusti uzeti dozu Zydeliga i sjeti se unutar 6 sati od vremena kad je obično uzima, treba uzeti propuštenu dozu što prije i nastaviti s uobičajenim rasporedom uzimanja lijeka.
Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of these enzymes (warfarin, phenytoin, S-mephenytoin).
Savjetuje se oprez ako se Zydelig primjenjuje zajedno s lijekovima uske terapijske širine koji su supstrati ovih enzima (varfarin, fenitoin, S-mefenitoin).
ENDOTHELIN RECEPTOR ANTAGONISTS
ANTAGONISTI ENDOTELINSKIH
If the event recurs, treatment with Zydelig must be withheld until the values return to Grade 1 or less, after which re-initiation at 100 mg twice daily may be considered at the discretion of the physician (see sections 4.4 and 4.8).
Ako se povišenje ponovi, liječenje Zydeligom mora se prekinuti sve dok se vrijednosti ne vrate na 1. stupanj ili niže, nakon čega se može razmotriti ponovno uvođenje 100 mg dva puta dnevno, prema procjeni liječnika (vidjeti dijelove 4.4 i 4.8).
This occurs in approximately two-thirds of patients with CLL treated with idelalisib monotherapy and one-fourth of patients with CLL treated with idelalisib combination therapy.
To je zabilježeno u približno dvije trećine bolesnika s KLL-om liječenih idelalisibom kao monoterapijom i jednoj četvrtini bolesnika s KLL-om liječenih idelalisibom u kombiniranoj terapiji.
The adverse drug reactions reported with idelalisib alone or in combination with anti-CD20 monoclonal antibodies (rituximab or ofatumumab) are provided in Table 2.
Zabilježene nuspojave pri uzimanju idelalisiba u monoterapiji ili u kombinaciji s anti-CD20 monoklonskim protutijelima (rituksimabom ili ofatumumabom) prikazane su u tablici 2.
Following a single 150 mg dose, no clinically relevant changes in exposures to idelalisib or GS-563117 were observed in subjects with severe renal impairment compared to healthy subjects.
Nakon jedne doze od 150 mg nisu uočene klinički značajne promjene u izloženosti idelalisibu ili GS-563117 u ispitanika s teškim oštećenjem funkcije bubrega u usporedbi sa zdravim ispitanicima.
The Kaplan-Meier curve for PFS is provided in Figure 1.
Kaplan-Meierova krivulja PFS-a prikazana je na slici 1.
Following a single 150 mg dose, idelalisib AUC (total, i.e., bound plus unbound) was ~60% higher in moderate and severe impairment compared to matched controls.
Nakon jedne doze od 150 mg AUC idelalisiba (ukupnog, tj. vezanog i nevezanog zajedno) bila je ~60% veća u ispitanika s umjerenim i teškim oštećenjem u usporedbi s odgovarajućim kontrolnim ispitanicima.
Chronic lymphocytic leukaemia (CLL) is a cancer of a type of white blood cell called B-lymphocytes.
Kronična limfocitna leukemija (KLL) je rak vrste bijelih krvnih stanica koje se zovu B limfociti.
Effect of other medicinal products on idelalisib pharmacokinetics
Učinak drugih lijekova na farmakokinetiku idelalisiba
Population pharmacokinetic analyses indicated that age had no clinically relevant effect on the exposures to idelalisib or GS-563117, including elderly subjects (65 years of age and older), compared to younger subjects.
Populacijska analiza farmakokinetike pokazala je da dob nema klinički značajan učinak na izloženost idelalisibu ili GS-563117, što obuhvaća i usporedbu starijih ispitanika (u dobi od 65 godina i stariji) s mlađima.
Co-administration of Zydelig with moderate or strong CYP3A inducers such as rifampicin, phenytoin, St. John's wort, or carbamazepine should be avoided as this may result in decreased efficacy (see section 4.4).
Istovremenu primjenu Zydeliga s umjerenim ili jakim CYP3A induktorima kao što su rifampicin, fenitoin, gospina trava ili karbamazepin treba izbjegavati, jer može dovesti do smanjenja djelotvornosti (vidjeti dio 4.4).