FrancophonIA/ELRC3.0 huggingface dataset:
English: • alfuzosin, a medicine used to treat an enlarged prostate • dabigatran, warfarin, medicines used to thin the blood
Croatian: • alfuzosin, lijek koji se primjenjuje za liječenje povećane prostate • dabigatran, varfarin, lijekovi koji se primjenjuju za razrjeđivanje krvi
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Idelalisib exposure may be reduced when co-administered with CYP3A inducers such as rifampicin, phenytoin, St. John's wort (Hypericum perforatum), or carbamazepine.
Croatian: Izloženost idelalisibu može biti smanjena ako se primjenjuje istovremeno s CYP3A induktorima kao što su rifampicin, fenitoin, gospina trava (Hypericum perforatum) ili karbamazepin.
English: PHOSPHODIESTERASE INHIBITORS
Croatian: INHIBITORI FOSFODIESTERAZE
English: Once pneumonitis has resolved and if re-treatment is appropriate, resumption of treatment at 100 mg twice daily can be considered.
Croatian: Kada se pneumonitis povuče i ako bude prikladno ponoviti liječenje, može se razmotriti nastavak liječenja dozom od 100 mg dva puta dnevno.
English: 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.
Croatian: 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.
English: Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of these enzymes (warfarin, phenytoin, S-mephenytoin).
Croatian: Savjetuje se oprez ako se Zydelig primjenjuje zajedno s lijekovima uske terapijske širine koji su supstrati ovih enzima (varfarin, fenitoin, S-mefenitoin).
English: ENDOTHELIN RECEPTOR ANTAGONISTS
Croatian: ANTAGONISTI ENDOTELINSKIH
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: The adverse drug reactions reported with idelalisib alone or in combination with anti-CD20 monoclonal antibodies (rituximab or ofatumumab) are provided in Table 2.
Croatian: Zabilježene nuspojave pri uzimanju idelalisiba u monoterapiji ili u kombinaciji s anti-CD20 monoklonskim protutijelima (rituksimabom ili ofatumumabom) prikazane su u tablici 2.
English: 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.
Croatian: 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.
English: The Kaplan-Meier curve for PFS is provided in Figure 1.
Croatian: Kaplan-Meierova krivulja PFS-a prikazana je na slici 1.
English: 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.
Croatian: 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.
English: Chronic lymphocytic leukaemia (CLL) is a cancer of a type of white blood cell called B-lymphocytes.
Croatian: Kronična limfocitna leukemija (KLL) je rak vrste bijelih krvnih stanica koje se zovu B limfociti.
English: Effect of other medicinal products on idelalisib pharmacokinetics
Croatian: Učinak drugih lijekova na farmakokinetiku idelalisiba
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Therefore, women of childbearing potential must use highly effective contraception while taking Zydelig and for 1 month after stopping treatment.
Croatian: Stoga žene reproduktivne dobi moraju koristiti visoko učinkovitu kontracepciju dok uzimaju Zydelig i još mjesec dana nakon prestanka liječenja.
English: Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4).
Croatian: Jedna tableta sadrži 0,1 mg boje sunset yellow FCF (E110) (vidjeti dio 4.4).
English: Higher frequencies of infections overall, including Grade 3 and 4 infections, were observed in the idelalisib arms compared to the control arms of idelalisib clinical studies.
Croatian: U skupinama liječenim idelalisibom uočene su veće učestalosti svih infekcija, uključujući infekcije 3. i 4. stupnja, u usporedbi s kontrolnim skupinama u kliničkim ispitivanjima idelalisiba.
English: Idelalisib should not be co-administered with midazolam (oral) or triazolam.
Croatian: Idelalisib se ne smije istovremeno primjenjivati s midazolamom (uzimanim peroralno) ili triazolamom.
English: There are no or limited amount of data from the use of idelalisib in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni idelalisiba u trudnica ograničeni.
English: Following oral administration of a single dose of idelalisib, peak plasma concentrations were observed 2 to 4 hours post-dose under fed conditions and after 0.5 to 1.5 hours under fasted conditions.
Croatian: Nakon primjene jedne doze idelalisiba peroralno vršna koncentracija u plazmi postiže se za 2 - 4 sata ako je doza uzeta s hranom i za 0,5 - 1,5 sati ako je uzeta natašte.
English: Skin and subcutaneous tissue disorders Rash***
Croatian: Poremećaji kože i potkožnog tkiva Osip***
English: The ORR was 96.9%, with 12 CRs (18.8%) and 50 PRs (78.1%), including 3 CRs and 6 PRs in subjects with a 17p deletion and/or TP53 mutation and 2 CRs and 34 PRs in subjects with unmutated IGHV.
Croatian: ORR je iznosio 96,9% s 12 CR-ova (18,8%) i 50 PR-ova (78,1%), uključujući 3 CR-a i 6 PR-ova u ispitanika s delecijom 17p i/ili mutacijom TP53 te 2 CR-a i 34 PR-a u ispitanika s nemutiranim IGHV.
English: No human data on the effect of idelalisib on fertility are available.
Croatian: Nema podataka o utjecaju idelalisiba na plodnost ljudi.
English: Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of CYP2C8 (paclitaxel).
Croatian: Savjetuje se oprez ako se Zydelig primjenjuje zajedno s lijekovima uske terapijske širine koji su supstrati CYP2C8 (paklitaksel).
English: • cisapride, a medicine used to relieve certain stomach problems
Croatian: • cisaprid, lijek koji se primjenjuje za ublažavanje određenih želučanih tegoba
English: Cases of pneumonitis and organising pneumonia (some with fatal outcome) have been reported with idelalisib.
Croatian: Zabilježeni su slučajevi pneumonitisa i organizirajuće pneumonije (neki sa smrtnim ishodom) s idelalisibom.
English: Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
Croatian: Idelalisib inducira apoptozu i inhibira proliferaciju staničnih linija dobivenih iz zloćudnih B-stanica te primarnih tumorskih stanica.
English: Its primary metabolite is GS-563117, which is not pharmacologically active.
Croatian: Njegov primarni metabolit je GS-563117 koji nije farmakološki aktivan.
English: Blood counts should be monitored in all patients at least every 2 weeks for the first 6 months of treatment with idelalisib, and at least weekly in patients while ANC is less than 1,000 per mm3 (see section 4.2).
Croatian: Potrebno je pratiti krvnu sliku u svih bolesnika najmanje svaka 2 tjedna tijekom prvih 6 mjeseci liječenja idelalisibom, a najmanje jednaput tjedno dok je u bolesnika ABN manji od 1000 po mm
English: Following 150 mg twice daily administration of idelalisib, average (range) Cmax and AUC at steady-state were 1,953 (272; 3,905) ng/mL and 10,439 (2,349; 29,315) ng•h/mL for idelalisib and 4,039 (669; 10,897) ng/mL and 39,744 (6,002; 119,770) ng•h/mL for GS-563117, respectively.
Croatian: Nakon primjene 150 mg idelalisiba dva puta dnevno prosječna (raspon) Cmax i AUC u stanju dinamičke ravnoteže iznosile su 1953 (272; 3905) ng/ml i 10 439 (2349; 29 315) ng•h/ml za idelalisib te 4039 (669; 10 897) ng/ml i 39 744 (6002; 119 770) ng•h/ml za GS-563117.
English: The Kaplan-Meier curve for PFS is provided in Figure 2.
Croatian: Kaplan-Meierova krivulja PFS-a prikazana je na slici 2.
English: Follicular lymphoma (FL) is a cancer of a type of white blood cell called B-lymphocytes.
Croatian: Folikularni limfom (FL) je rak vrste bijelih krvnih stanica koje se zovu B limfociti.
English: ANC should be monitored at least weekly until ANC is ≥ 500 per mm3 when treatment can be resumed at 100 mg twice daily (see section 4.4).
Croatian: ABN treba pratiti najmanje jedanput tjedno sve dok ne bude ≥ 500 po mm3, kada se liječenje može nastaviti u dozi od 100 mg dvaput na dan (vidjeti dio 4.4).
English: Study 312-0119 was a Phase 3, randomised, open-label, multicentre, parallel-group study in 261 subjects with previously treated CLL who had measurable lymphadenopathy, required treatment, and experienced CLL progression < 24 months since the completion of the last prior therapy.
Croatian: Ispitivanje 312-0119 bilo je randomizirano, otvoreno, multicentrično ispitivanje faze 3 na usporednim skupinama provedeno u 261 ispitanika prethodno liječenih zbog KLL koji su imali mjerljivu limfadenopatiju, zahtijevali liječenje i u kojih je progresija KLL nastupila za < 24 mjeseca od završetka zadnje prethodne terapije.
English: In vitro data indicated that idelalisib is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A, or UGT1A1, or of the transporters OAT1, OAT3, or OCT2.
Croatian: In vitro podaci pokazali su da idelalisib nije inhibitor metaboličkih enzima CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A ili UGT1A1 ili prijenosnika OAT1, OAT3 ili OCT2.
English: The first infusion of ofatumumab was administered at a dose of 300 mg and was continued at a dose of either 1,000 mg in the idelalisib + ofatumumab group or a dose of 2,000 mg in the ofatumumab only group, weekly for 7 doses, and then every 4 weeks for 4 doses.
Croatian: Ofatumumab se u prvoj infuziji primijenio u dozi od 300 mg te se nastavio primjenjivati u dozi od 1000 mg u skupini koja je primala idelalisib + ofatumumab ili u dozi od 2000 mg u skupini koja je primala samo ofatumumab svakog tjedna dok se nije primijenilo 7 doza, a potom svaka 4 tjedna dok se nije primijenilo 4 doze.
English: ANC 500 to < 1,000/mm3
Croatian: ABN 500 do < 1000/mm3
English: No dose adjustment is required when initiating treatment with Zydelig in patients with mild or moderate hepatic impairment, but an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Croatian: Nije potrebna prilagodba doze za početak liječenja Zydeligom u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre, ali se preporučuje pojačani nadzor zbog nuspojava (vidjeti dijelove 4.4 i 5.2).
English: Effect of idelalisib on the pharmacokinetics of other medicinal products
Croatian: Učinak idelalisiba na farmakokinetiku drugih lijekova
English: The primary and only circulating metabolite, GS-563117, is inactive against PI3Kδ.
Croatian: Njegov primarni i jedini cirkulirajući metabolit, GS-563117, je inaktivan prema PI3Kδ.
English: • dihydroergotamine, ergotamine, medicines used to treat migraine headache
Croatian: • dihidroergotamin, ergotamin, lijekovi koji se primjenjuju za liječenje migrene
English: Ergotamine, dihydroergotamine ↑ serum concentrations Idelalisib should not be co-administered with ergotamine or dihydroergotamine.
Croatian: ERGOT ALKALOIDI Ergotamin, dihidroergotamin ↑ koncentracije u serumu Idelalisib se ne smije istovremeno primjenjivati s ergotaminom ili dihidroergotaminom.
English: Interrupt Zydelig dosing.
Croatian: Prekinite doziranje Zydeliga.
English: • if you have swelling and blistering of the lining of the mouth, genitals, and/or eyes
Croatian: • ako imate oticanje i mjehure na sluznici usta, spolnih organa i/ili očiju.
English: Therefore, caution is recommended when administering Zydelig in this population and an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Croatian: Zbog toga se preporučuje oprez i pojačani nadzor zbog nuspojava pri primjeni Zydeliga u ovoj populaciji (vidjeti dijelove 4.4 i 5.2).
English: Figure 1: Kaplan-Meier curve of PFS from study 312-0116 (intent-to-treat population)
Croatian: Slika 1: Kaplan-Meierova krivulja PFS-a u ispitivanju 312-0116 (populacija s namjerom liječenja)
English: The primary endpoint was PFS. Efficacy results are summarised in Tables 5 and 6.
Croatian: Rezultati djelotvornosti sažeti su u tablicama 5 i 6.
English: No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze za bolesnike s blagim, umjerenim ili teškim oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Following a single 150 mg oral dose of [14C]-labelled idelalisib, approximately 78% and 15% was excreted in faeces and urine, respectively.
Croatian: Nakon jednokratne peroralne doze od 150 mg idelalisiba označenog ugljikom [14C] približno 78% izlučeno je stolicom, a 15% mokraćom.
English: * ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) based on the 2013 National Comprehensive Cancer Network (NCCN) response criteria and Cheson (2012).
Croatian: * ORR je definiran kao udio ispitanika koji su postigli potpuni odgovor (CR, complete response) ili parcijalni odgovor (PR, partial response) prema kriterijima odgovora National Comprehensive Cancer Network (NCCN)
English: Among the 122 subjects with measurable lymph nodes at both baseline and post-baseline, 71 subjects (58.2%) achieved a ≥ 50% decrease from baseline in the sum of the products of the diameters (SPD) of index lesions.
Croatian: Od 122 ispitanika s mjerljivim limfnim čvorovima na prvom i kasnijim pregledima, 71 ispitanik (58,2%) dosegao je smanjenje zbroja umnožaka promjera (SPD) praćenih lezija ≥ 50% u odnosu na početak.
English: In rats, idelalisib has the potential to inhibit T-dependent antibody responses.
Croatian: Idelalisib je u štakora pokazao mogućnost inhibicije imunološkog odgovora protutijelima ovisnog o T limfocitima.
English: ↑ serum concentrations It is recommended that the international normalised ratio (INR) be monitored upon co-administration and following ceasing treatment with idelalisib.
Croatian: ↑ koncentracije u serumu Preporučuje se pratiti međunarodni normalizirani omjer (INR) pri istovremenoj primjeni i nakon prestanka liječenja idelalisibom.
English: No mechanistic explanations for the development of resistance to treatment with idelalisib have been identified from clinical studies.
Croatian: U kliničkim ispitivanjima nisu utvrđena objašnjenja mehanizma za razvoj rezistencije na liječenje idelalisibom.
English: CYP3A substrates
Croatian: CYP3A supstrati
English: Evaluation of the potential for phototoxicity in the embryonic murine fibroblast cell line BALB/c 3T3 was inconclusive for idelalisib due to cytotoxicity in the in vitro assay.
Croatian: Procjena moguće fototoksičnosti idelalisiba na staničnoj liniji BALB/c 3T3 embrionalnih fibroblasta miša nije dovela do konačnog zaključka zbog citotoksičnosti na in vitro testu.
English: Relative to fasting conditions, administration of an early capsule formulation of idelalisib with a highfat meal resulted in no change in Cmax and a 36% increase in mean AUCinf.
Croatian: U usporedbi s primjenom natašte, primjena idelalisiba u kapsuli formuliranoj u ranoj fazi razvoja lijeka s obrokom bogatim mastima nije uzrokovala promjene u Cmax, a srednja vrijednost AUCinf porasla je za 36%.
English: ↑ serum concentrations Careful monitoring of the tolerance to these anti-cancer agents is recommended.
Croatian: ↑ koncentracije u serumu Preporučuje se pažljivi nadzor tolerancije na ove antitumorske lijekove.
English: How to store Zydelig
Croatian: Kako čuvati Zydelig
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation (UGT1A4).
Croatian: Idelalisib se primarno metabolizira putem aldehid-oksidaze, a u manjoj mjeri putem CYP3A i glukuronidacije (UGT1A4).
English: Zydelig contains sunset yellow FCF (E110)
Croatian: Zydelig sadrži boju sunset yellow FCF (E110)
English: A clinical drug interaction study found that co-administration of a single dose of 400 mg idelalisib with 400 mg once daily ketoconazole (a strong CYP3A, P-gp and BCRP inhibitor) resulted in a 26% increase in Cmax and a 79% increase in AUCinf of idelalisib.
Croatian: Kliničko ispitivanje interakcija lijekova pokazalo je da istovremena primjena jedne doze od 400 mg idelalisiba s 400 mg ketokonazola jednom dnevno (jakim CYP3A, P-gp i BCRP inhibitorom) izaziva porast Cmax idelalisiba za 26% te porast AUCinf za 79%.
English: A clinical drug interaction study found that co-administration of idelalisib with midazolam (a sensitive CYP3A substrate) resulted in a ~140% increase in Cmax and a ~440% increase in AUCinf of midazolam due to the CYP3A inhibition by GS-563117.
Croatian: Kliničko ispitivanje interakcija lijekova pokazalo je da istovremena primjena idelalisiba s midazolamom (osjetljivim supstratom za CYP3A) izaziva porast Cmax midazolama za ~140% i AUCinf za ~440% zbog inhibicije CYP3A metabolitom GS-563117.
English: Midazolam (oral), triazolam
Croatian: SEDATIVI/HIPNOTICI Midazolam (uziman peroralno), triazolam
English: • amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
Croatian: • amlodipin, diltiazem, felodipin, nikardipin, nifedipin, lijekovi koji se primjenjuju za liječenje povišenog krvnog tlaka i srčanih tegoba
English: Table 3: Efficacy results from study 312-0116 Idelalisib + R N = 110
Croatian: Tablica 3: Rezultati djelotvornosti iz ispitivanja 312-0116 Idelalisib + R
English: Zydelig can cause severe diarrhoea.
Croatian: Zydelig može uzrokovati teški proljev.
English: Zydelig is for oral use.
Croatian: Zydelig se uzima peroralno.
English: Idelalisib should not be co-administered with amiodarone or quinidine.
Croatian: Idelalisib se ne smije istovremeno primjenjivati s amiodaronom ili kinidinom.
English: • buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
Croatian: • buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem, lijekovi koji se primjenjuju za liječenje poremećaja živčanog sustava
English: Fentanyl, alfentanil, methadone, buprenorphine/naloxone
Croatian: ANALGETICI Fentanil, alfentanil, metadon, buprenorfin/nalokson
English: Figure 2: Kaplan-Meier curve of PFS from study 312-0119 (intent-to-treat population)
Croatian: Slika 2: Kaplan Meierova krivulja PFS-a u ispitivanju 312-0119 (populacija s namjerom liječenja)
English: *** Includes the preferred terms dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule, skin plaque, and exfoliative rash.
Croatian: *** Uključuje preporučene izraze: 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, plak na koži i eksfolijativni osip.
English: Serious and fatal infections have occurred in patients taking Zydelig.
Croatian: U bolesnika koji uzimaju Zydelig pojavile su se ozbiljne i smrtonosne infekcije.
English: The terminal elimination half-life of idelalisib was 8.2 (range: 1.9; 37.2) hours and the apparent clearance of idelalisib was 14.9 (range: 5.1; 63.8) L/h following idelalisib 150 mg twice daily oral administration.
Croatian: Poluvrijeme terminalne eliminacije idelalisiba bilo je 8,2 (raspon: 1,9 - 37,2) sata, a prividni klirens 14,9 (raspon: 5,1 - 63,8) l/h nakon peroralne primjene 150 mg dva puta dnevno.
English: CI: confidence interval; O: ofatumumab; N: number of subjects per group
Croatian: CI: interval pouzdanosti; O: ofatumumab; N: broj ispitanika u skupini
English: If the event does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician.
Croatian: Ako se povišenje ne ponovi, doza se može ponovno povećati na 150 mg dva puta dnevno, prema procjeni nadležnog liječnika.
English: ↑ serum concentrations Increased monitoring for rifabutinassociated adverse reactions including neutropenia and uveitis is recommended.
Croatian: ↑ koncentracije u serumu Preporučuje se pojačan nadzor zbog nuspojava povezanih s rifabutinom uključujući neutropeniju i uveitis.
English: HMG CO-A REDUCTASE INHIBITORS
Croatian: INHIBITORI HMG-CoA REDUKTAZE Lovastatin, simvastatin
English: A clinical drug interaction study found that co-administration of a single dose of 150 mg idelalisib with rifampicin (a strong CYP3A inducer) resulted in a ~75% reduction in idelalisib AUCinf.
Croatian: Kliničko ispitivanje interakcija lijekova pokazalo je da istovremena primjena jedne doze od 150 mg idelalisiba s rifampicinom (jakim CYP3A induktorom) izaziva smanjenje AUCinf idelalisiba za ~75%.
English: Clinical recommendation upon co-administration with idelalisib
Croatian: Klinička preporuka za istovremenu primjenu s idelalisibom
English: It is not known whether the active substance in Zydelig passes into human milk.
Croatian: Nije poznato izlučuje li se djelatna tvar iz Zydeliga u majčino mlijeko.