FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Do tega pride pri približno dveh tretjinah bolnikov s kronično limfocitno levkemijo (KLL), zdravljenih z monoterapijo idelaliziba, in eni četrtini bolnikov s KLL, zdravljenih s kombinatorno terapijo idelaliziba.
English: Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4).
Slovenian: Ena tableta vsebuje 0,1 mg barvila sončno rumeno FCF (E110) (glejte poglavje 4.4).
English: CI: confidence interval; n: number of responding subjects NR: not reached * Response as determined by an independent review committee (IRC) where ORR = complete response (CR) + partial response (PR) + minor response (MR) in subjects with WM. † In the overall iNHL cohort, 1 subject (0.6%) with WM had the best overall response of MR
Slovenian: ND: ni doseženo * Odziv, kot ga je opredelil neodvisni odbor za pregled (IRC-independent review committee), pri čemer je ORR = celovit odziv (CR) + delni odziv (PR) + manjši odziv (MR) pri osebah z WM. † V celokupni kohorti iNHL je imela 1 oseba (0,6 %) z WM najboljši celokupni odziv MR.
English: Subjects received 150 mg of idelalisib orally twice daily until evidence of disease progression or unacceptable toxicity.
Slovenian: Osebe so prejemale 150 mg idelaliziba peroralno dvakrat na dan do dokazanega napredovanja bolezni ali nesprejemljive toksičnosti.
English: Rash typically resolved with treatment (e.g., topical and/or oral steroids, diphenhydramine) and dose interruption for severe cases (see section 5.3, phototoxicity).
Slovenian: Običajno je izpuščaj izzvenel z zdravljenjem (npr. topikalni in/ali peroralni steroidi, difenhidramin) in prekinitvijo odmerjanja v hudih primerih (glejte poglavje 5.3, fototoksičnost).
English: In patients presenting with serious lung events, idelalisib should be interrupted and the patient assessed for an explanatory aetiology.
Slovenian: Pri bolnikih z resnimi pljučnimi dogodki je treba uporabo idelaliziba prekiniti in bolnika oceniti za obrazložitveno etiologijo.
English: The median DOR for all subjects was 12.5 months (12.5 months for SLL subjects, and 11.8 months for FL, 20.4 months for LPL/WM and 18.4 months for MZL subjects).
Slovenian: Mediana DOR za vse osebe je bila 12,5 mesecev (12,5 mesecev za osebe s SLL in 11,8 meseca za osebe s FL, 20,4 meseca za osebe z LPL/WM in 18,4 meseca za osebe z MZL).
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.
Slovenian: Če bolnik izpusti odmerek zdravila Zydelig v roku 6 ur, ko ga običajno vzame, mora bolnik vzeti izpuščeni odmerek takoj, ko je mogoče, nato pa nadaljevati z običajnim režimom odmerjanja.
English: The primary endpoint was progression free survival (PFS).
Slovenian: Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS-progression free survival).
English: Zydelig is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Zydelig ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Pneumonitis and organising pneumonia
Slovenian: Pnevmonitis in organizirajoča pljučnica
English: Infections and infestations Infections (including Pneumocystis jirovecii pneumonia and CMV)*
Slovenian: Infekcijske in parazitske bolezni okužbe (vključno s pljučnico, povzročeno s Pneumocystis jirovecii, in okužbo s CMV)*
English: Subjects were randomised 1:1 to receive 8 cycles of rituximab (first cycle at 375 mg/m2 body surface area [BSA], subsequent cycles at 500 mg/m2 BSA) in combination with either an oral placebo twice daily or with idelalisib 150 mg taken twice daily until disease progression or unacceptable toxicity.
Slovenian: Osebe so bile randomizirane v razmerju 1:1 na prejemanje 8 ciklov rituksimaba (prvi cikel 375 mg/m2 telesne površine [BSA-body surface area], naslednji cikli 500 mg/m2 BSA) v kombinaciji z bodisi peroralnim placebom dvakrat na dan ali z idelalizibom 150 mg dvakrat na dan do napredovanja bolezni ali nesprejemljive toksičnosti.
English: ^ Overall survival (OS) analysis includes data from subjects who received placebo + R on study 312-0116 and subsequently received idelalisib in an extension study, based on intent-to-treat analysis.
Slovenian: ^ Analiza celokupnega preživetja (OS-overall survival) vključuje podatke oseb, ki so prejemali placebo + R v študiji 312-0116 in so nato v podaljšani študiji prejemali idelalizib (na podlagi analize z-namenom zdravljenja).
English: Elevated liver transaminases
Slovenian: Povečanje jetrnih transaminaz
English: Cases of progressive multifocal leukoencephalopathy (PML) have been reported following the use of idelalisib within the context of prior or concomitant immunosuppressive therapies that have been associated with PML.
Slovenian: Po uporabi idelaliziba so poročali o primerih progresivne multifokalne levkoencefalopatije (PML) ob predhodnem ali sočasnem zdravljenju z imunosupresivi, ki so povezani s PML.
English: Amlodipine, diltiazem, felodipine, nifedipine, nicardipine
Slovenian: amlodipin, diltiazem, felodipin, nifedipin, nikardipin
English: 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).
Slovenian: Varnost in učinkovitost idelaliziba so ocenili v multicentrični klinični študiji z enim krakom (študija 101-09), v katero je bilo zajetih 125 oseb z indolentnim ne-Hodgkinovim limfomom celic B (iNHL, vključno s: FL, n = 72; SLL, n = 28; limfoplazmocitni limfom/Waldenströmova makroglobulinemija [LPL/WM], n = 10; in limfom marginalne cone [MZL-marginal zone lymphoma], n = 15).
English: Substrates of inducible enzymes (e.g., CYP2C9, CYP2C19, CYP2B6 and UGT) In vitro, idelalisib was an inducer of several enzymes, and a risk for decreased exposure and thereby decreased efficacy of substrates of inducible enzymes such as CYP2C9, CYP2C19, CYP2B6 and UGT cannot be excluded.
Slovenian: Substrati inducibilnih encimov (npr. CYP2C9, CYP2C19, CYP2B6 in UGT) In vitro je bil idelalizib induktor številnih encimov, tveganja za zmanjšanje izpostavljenosti in s tem manjše učinkovitosti substratov inducibilnih encimov, kot so CYP2C9, CYP2C19, CYP2B6 in UGT, pa ni mogoče izključiti.
English: Compared with rituximab + placebo, treatment with idelalisib + rituximab resulted in statistically significant and clinically meaningful improvements in physical well-being, social well-being, functional well-being, as well as in the leukaemia-specific subscales of the Functional Assessment of Cancer Therapy: Leukaemia (FACT-LEU) instruments, and in statistically significant and clinically meaningful improvements in anxiety, depression and usual activities as measured by the EuroQoL Five-Dimensions (EQ-5D) instrument.
Slovenian: V primerjavi z rituksimabom + placebom je zdravljenje z idelalizibom + rituksimabom povzročilo statistično značilna in klinično pomembna izboljšanja fizičnega dobrega počutja, socialnega dobrega počutja, funkcionalnega dobrega počutja in podlestvic orodij za funkcionalno oceno zdravljenja raka, specifičnih za levkemijo (FACT-LEU-Functional Assessment of Cancer Therapy: Leukaemia), in statistično značilna in klinično pomembna izboljšanja tesnobnosti, potrtosti in običajnih dejavnosti, izmerjeno s petdimenzionalnim orodjem EuroQoL (EQ-5D).
English: In studies up to 4 weeks in rats and dogs, hepatic necrosis was observed at 7 and 5 times the human exposure based on AUC, respectively.
Slovenian: V do 4 tedne trajajočih študijah pri podganah in psih so pri izpostavljenosti, ki je bila 7- oz. 5-krat večja kot je izpostavljenost človeka na podlagi AUC, opazili jetrno nekrozo.
English: Clinical monitoring is recommended.
Slovenian: Priporoča se klinično spremljanje.
English: Concomitant treatment of idelalisib with CYP3A substrates with serious and/or life-threatening adverse reactions (e.g., alfuzosin, amiodarone, cisapride, pimozide, quinidine, ergotamine, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam) should be avoided and alternative medicinal products that are less sensitive to CYP3A4 inhibition should be used if possible.
Slovenian: Sočasnemu zdravljenju z idelalizibom in substrati CYP3A, ki povzroča resne in/ali življenjsko ogrožajoče neželene učinke (npr. alfuzosin, amiodaron, cisaprid, pimozid, kinidin, ergotamin, dihidroergotamin, kvetiapin, lovastatin, simvastatin, sildenafil, midazolam, triazolam), se je treba izogniti in uporabiti alternativna zdravila, ki so manj občutljiva na zaviranje CYP3A4, če je mogoče.
English: Idelalisib was taken until disease progression or unacceptable toxicity.
Slovenian: Idelalizib se je jemal do napredovanja bolezni ali nesprejemljive toksičnosti.
English: What Zydelig looks like and contents of the pack
Slovenian: Izgled zdravila Zydelig in vsebina pakiranja
English: Treatment with Zydelig must be withheld in the event of a Grade 3 or 4 aminotransferase elevation (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] > 5 x upper limit of normal [ULN]).
Slovenian: Zdravljenje z zdravilom Zydelig je treba začasno ustaviti, če se pojavi povečanje aminotransferaze 3. ali 4. stopnje (alanin aminotransferaza [ALT]/aspartat aminotransferaza [AST] > 5 x zgornja meja normalne vrednosti [ULN-upper limit of normal]).
English: • trazodone, a medicine used to treat depression
Slovenian: • trazodon, zdravilo, ki se uporablja za zdravljenje depresije
English: ↑ serum concentrations Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.
Slovenian: ↑ koncentracij v serumu Priporoča se skrbno titriranje odmerka antidepresiva in spremljanje odziva na antidepresiv.
English: Animal studies indicate the potential for harmful effects of idelalisib on fertility and foetal development (see section 5.3).
Slovenian: Študije na živalih kažejo na možne škodljive učinke idelaliziba na plodnost in razvoj zarodka (glejte poglavje 5.3).
English: No initial dose adjustment of idelalisib is considered necessary when administered with CYP3A/P-gp inhibitors, but an intensified monitoring of adverse reactions is recommended.
Slovenian: Smatrajo, da prilagoditev začetnega odmerka idelaliziba pri sočasnem dajanju z zaviralci CYP3A/P-gp ni potrebna, vendar se priporoča intenzivnejše spremljanje neželenih učinkov.
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.
Slovenian: Ocenitev potenciala za fototoksičnost v embrionski celični liniji fibroblastov miši BALB/c 3T3 za idelalizib ni bila sklepčna zaradi citotoksičnosti testa in vitro.
English: If you miss a dose by less than 6 hours, take the missed dose right away.
Slovenian: Če odmerek izpustite za manj kot 6 ur, takoj vzemite izpuščeni odmerek.
English: • midazolam, triazolam, when taken by mouth to help you sleep and/or relieve anxiety
Slovenian: • midazolam, triazolam; kadar se uporabljata peroralno kot pomoč pri spanju in/ali za lajšanje tesnobe
English: What Zydelig is and what it is used for What you need to know before you take Zydelig How to take Zydelig
Slovenian: Kaj je zdravilo Zydelig in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Zydelig Kako jemati zdravilo Zydelig Možni neželeni učinki
English: • atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol
Slovenian: • atorvastatin, lovastatin, simvastatin; zdravila, ki se uporabljajo za nižanje holesterola
English: ANC 1,000 to < 1,500/mm3
Slovenian: ANC 1.000 do < 1.500/mm3
English: Population pharmacokinetic analyses indicated that gender and race had no clinically relevant effect on the exposures to idelalisib or GS-563117.
Slovenian: Analize populacijske farmakokinetike kažejo, da spol in rasa nimata klinično pomembnega učinka na izpostavljenost idelalizibu ali GS-563117.
English: ↑ serum concentrations Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
Slovenian: ↑ koncentracij v serumu Priporoča se skrbno spremljanje neželenih učinkov (npr. respiratorna depresija, sedacija).
English: Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).
Slovenian: Zdravilo Zydelig je indicirano kot monoterapija za zdravljenje odraslih bolnikov s folikularnim limfomom (FL), neodzivnim na dve predhodni obliki zdravljenja (glejte poglavje 4.4).
English: Further investigation of this topic in current B-cell malignancy studies is not planned.
Slovenian: V študijah malignosti celic B, ki so v teku, ne načrtujejo dodatnih raziskav v zvezi s tem.
English: For patients with CrCl < 60 mL/min, alternative antibacterials should be considered.
Slovenian: Pri bolnikih s CrCl < 60 ml/min je treba razmisliti o uporabi alternativnega zdravila za zdravljenje okužb z bakterijami.
English: The Kaplan-Meier curve for PFS is provided in Figure 2.
Slovenian: Kaplan-Meierjeva krivulja za PFS je na sliki 2.
English: Tyrosine kinase inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine
Slovenian: zaviralci tirozin kinaze, kot so dasatinib in nilotinib, tudi vinkristin in vinblastin
English: ANC 500 to < 1,000/mm3
Slovenian: ANC 500 do < 1.000/mm3
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.
Slovenian: Analize populacijske farmakokinetike kažejo, da starost nima klinično pomembnega učinka na izpostavljenost idelalizibu ali GS-563117, vključno s starejšimi osebami (65 let in več), v primerjavi z mlajšimi osebami.
English: No human data on the effect of idelalisib on fertility are available.
Slovenian: Podatki o vplivu idelaliziba na plodnost pri ljudeh niso na voljo.
English: What you need to know before you take Zydelig Do not take Zydelig
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zydelig Ne jemljite zdravila Zydelig
English: Very common
Slovenian: zelo pogosti pogosti
English: • bosentan, a medicine used to treat pulmonary arterial hypertension
Slovenian: • bosentan, zdravilo, ki se uporablja za zdravljenje pljučne arterijske hipertenzije
English: If you accidentally take more than the recommended dose of Zydelig, you may be at increased risk of side effects with this medicine (see section 4, Possible side effects).
Slovenian: Če ste vzeli večji odmerek zdravila Zydelig, kot bi smeli Če ste pomotoma zaužili odmerek zdravila Zydelig, višji od priporočenega, obstaja povečano tveganje za neželene učinke tega zdravila (glejte poglavje 4, Možni neželeni učinki).
English: 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.
Slovenian: Vrednost AUC idelaliziba (nevezanega) je bila po upoštevanju razlik pri vezavi na beljakovine ~ 80 (1,8-krat) % višja pri zmerni in ~ 152 % (2,5-krat) višja pri hudi okvari v primerjavi z ustrezno kontrolno skupino.
English: There is a potential risk that idelalisib, via its major metabolite, GS-563117, may cause photosensitivity in treated patients.
Slovenian: Obstaja potencialno tveganje, da bi lahko idelalizib, prek svojega glavnega presnovka, GS-563117, povzročil fotosenzitivnost pri zdravljenih bolnikih.
English: Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
Slovenian: Idelalizib povzroči apoptozo in zavira proliferacijo celičnih linij, ki nastajajo iz malignih celic B in v celicah primarnega tumorja.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX47
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX47
English: Women of childbearing potential must use highly effective contraception while taking idelalisib and for 1 month after stopping treatment (see section 4.6).
Slovenian: Ženske v rodni dobi morajo med jemanjem idelaliziba in še 1 mesec po prenehanju zdravljenja uporabljati zelo učinkovito kontracepcijo (glejte poglavje 4.6).
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.
Slovenian: Po peroralnem dajanju enega odmerka idelaliziba so največje koncentracije v plazmi opazili 2 do 4 ure po odmerjanju s hrano in po 0,5 do 1,5 ure na tešče.
English: • The active substance is idelalisib.
Slovenian: • Učinkovina je idelalizib.
English: Zydelig contains sunset yellow FCF which may cause allergic reactions.
Slovenian: Zdravilo Zydelig vsebuje barvilo sončno rumeno FCF, ki lahko povzroči alergijske reakcije.
English: Idelalisib + O 174 (0) 162 (6) 151 (13) 140 (22) 129 (31) 110 (45) 82 (57) 44 (67) 37 (70) 7 (76) 1 (76) 0 (76) Ofatumumab 87 (0) 60 (14) 47 (21) 34 (30) 26 (34) 11 (49) 8 (51) 6 (52) 6 (52) 2 (54) 0 (54) 0 (54)
Slovenian: Idelalizib + O 174 (0) 162 (6) 151 (13) 140 (22) 129 (31) 110 (45) 82 (57) 44 (67) 37 (70) 7 (76) 1 (76) 0 (76) Ofatumumab 87 (0) 60 (14) 47 (21) 34 (30) 26 (34) 11 (49) 8 (51) 6 (52) 6 (52) 2 (54) 0 (54) 0 (54)
English: High density polyethylene (HDPE) bottle, capped with a polypropylene child-resistant closure, containing 60 film-coated tablets and a polyester coil.
Slovenian: Plastenka, narejena iz polietilena visoke gostote (HDPE-high density polyethylene), zaprta z za otroke varno zaporko iz polipropilena, vsebuje 60 filmsko obloženih tablet in poliestrsko vato.
English: Skin and subcutaneous tissue disorders Rash***
Slovenian: Bolezni kože in podkožja izpuščaj***
English: Blistering can also involve the lining of the mouth, genitals, and/or eyes.
Slovenian: Mehurji se lahko pojavijo tudi na ustni sluznici, spolovilih in/ali očeh.
English: Neutropenia Treatment with Zydelig should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm3.
Slovenian: Zdravljenje z zdravilom Zydelig je treba začasno ustaviti pri bolnikih z absolutnim številom nevtrofilcev (ANC) pod 500 na mm3.
English: Expected effect of idelalisib on drug levels
Slovenian: Pričakovani učinek idelaliziba na ravni zdravila
English: ANALGESICS
Slovenian: ANALGETIKI
English: 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.
Slovenian: Sočasno dajanje več odmerkov idelaliziba 150 mg dvakrat na dan zdravim osebam je povzročilo primerljive izpostavljenosti za rosuvastatin (AUC 90 % IZ: 87, 121) in digoksin (AUC 90 % IZ: 98, 111), kar kaže, da naj idelalizib ne bi klinično pomembno zaviral BCRP, OATP1B1/1B3 ali sistemskega P-gp.
English: Solid line: idelalisib + R (N = 110), dashed line: placebo + R (N = 110) R: rituximab; N: number of subjects per group
Slovenian: Polna črta: idelalizib + R (N = 110), prekinjena črta: placebo + R (N = 110) R: rituksimab; N: število oseb na skupino
English: If any doubt exists, referral to a neurologist and appropriate diagnostic measures for PML including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC viral DNA and repeat neurological assessments should be considered.
Slovenian: Ob vsakršnem dvomu je treba razmisliti o napotitvi k nevrologu in ustreznih diagnostičnih ukrepih za PML, vključno s slikanjem z magnetno resonanco, po možnosti s kontrastom, preiskavo za določanje prisotnosti DNA virusa JC v cerebrospinalni tekočini (CST) in ponovnimi nevrološkimi ocenami.
English: ** Idelalisib-induced lymphocytosis should not be considered progressive disease in the absence of other clinical findings (see section 5.1).
Slovenian: ** Brez prisotnosti drugih kliničnih rezultatov naj se z idelalizibom povzročene limfocitoze ne šteje za progresivno bolezen (glejte poglavje 5.1).
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Paediatric population The pharmacokinetics of idelalisib in paediatric subjects has not been established (see section 4.2).
Slovenian: Pediatrična populacija Farmakokinetike idelaliziba pri pediatričnih osebah niso ugotavljali (glejte poglavje 4.2).
English: Thus, idelalisib has the potential to interact with medicinal products that are metabolised by CYP3A, which may lead to increased serum concentrations of the other product (see section 4.5).
Slovenian: Zato lahko idelalizib medsebojno deluje z zdravili, ki jih CYP3A presnavlja, kar lahko povzroči povečane koncentracije drugih zdravil v serumu (glejte poglavje 4.5).
English: Solid line: idelalisib + O (N = 174), dashed line: ofatumumab (N = 87) O: ofatumumab; N: number of subjects per group
Slovenian: Polna črta: idelalizib + O (N = 174), prekinjena črta: ofatumumab (N = 87) O: ofatumumab; N: število oseb na skupino
English: Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Slovenian: Zdravilo Zydelig je indicirano v kombinaciji z rituksimabom za zdravljenje odraslih bolnikov s kronično limfocitno levkemijo (KLL):
English: Zydelig is for oral use.
Slovenian: Zdravilo Zydelig je za peroralno uporabo.
English: 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.
Slovenian: V študiji plodnosti pri podganjih samcih so opazili zmanjšanje mase obmodkov in mod, vendar pa niso opazili neželenih učinkov na parametre parjenja ali plodnosti oz. degeneracije ali izgube spermatogeneze.
English: Female fertility was not affected in rats.
Slovenian: Pri podganah plodnost samic ni bila prizadeta.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Slovenian: V primeru prevelikega odmerka je treba pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8).
English: Zydelig should not be used with any other medicines unless your doctor has told you it is safe to do so.
Slovenian: Druga zdravila in zdravilo Zydelig Zdravila Zydelig ne uporabljajte z drugimi zdravili, razen če zdravnik potrdi, da je to varno.
English: The Phase 1 and 2 studies assessed the safety of idelalisib in a total of 536 subjects with haematologic malignancies, including 400 subjects who received idelalisib (any dose) as a single agent and 136 subjects who received idelalisib in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab).
Slovenian: V študijah 1. in 2. faze so ocenili varnost idelaliziba pri skupaj 536 osebah s hematološkimi malignostmi, vključno s 400 osebami, ki so prejemale idelalizib (kateri koli odmerek) kot edino zdravilo, in 136 osebami, ki so idelalizib prejemale v kombinaciji z monoklonskim protitelesom proti CD20 (rituksimabom ali ofatumumabom).