natgillin/translations-raw huggingface dataset:
Of the 125 subjects enrolled, 80 (64%) were male, the median age was 64 years (range: 33 to 87), and 110 (89%) were white.
Od 125 vključenih oseb jih je bilo 80 (64 %) moških, mediana starost je bila 64 let (razpon: 33 do 87) in 110 (89 %) je bilo belcev.
Zydelig has no or negligible influence on the ability to drive and use machines.
Zdravilo Zydelig nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Treatment with Zydelig should be conducted by a physician experienced in the use of anti-cancer therapies.
Zdravljenje z zdravilom Zydelig mora voditi zdravnik z izkušnjami pri uporabi zdravil proti raku.
The effect of idelalisib (150 mg and 400 mg) on the QT/QTc interval was evaluated in a placebo- and positive-controlled (moxifloxacin 400 mg) crossover study in 40 healthy subjects.
Učinek idelaliziba (150 mg in 400 mg) na interval QT/QTc so ocenili v navzkrižni študiji, kontrolirani s placebom in pozitivno kontrolo (moksifloksacin 400 mg), s 40 zdravimi osebami.
• if you have liver problems
• če imate težave z jetri,
Idelalisib induced inflammatory changes in both rats and dogs.
Idelalizib je povzročil vnetne spremembe pri podganah in psih.
Blood tests may also show: • increased blood levels of fats
Krvne preiskave lahko pokažejo tudi: • povečanje ravni maščob v krvi
The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
Kombinacija lahko povzroči večje tveganje za kardiovaskularne neželene učinke, povezane s salmeterolom, vključno s podaljšanjem QT, palpitacijami in sinusno tahikardijo.
The onset of isolated lymphocytosis typically occurs during the first 2 weeks of idelalisib therapy and is often associated with reduction of lymphadenopathy.
Izolirana limfocitoza se tipično pojavi v prvih 2 tednih prejemanja terapije idelaliziba in je pogosto povezana z znižanjem limfadenopatije.
Assessment of adverse reactions is based on two Phase 3 studies (study 312-0116 and study 312-0119) and six Phase 1 and 2 studies.
Faze (študiji 312-0116 in študiji 312-0119) in šestih študijah 1. in 2. faze.
Co-administration of idelalisib with CYP3A substrates may increase their systemic exposures and increase or prolong their therapeutic activity and adverse reactions.
Sočasno dajanje idelaliziba s substrati CYP3A lahko poveča njihovo sistemsko izpostavljenost in poveča ali podaljša njihovo terapevtsko aktivnost in neželene učinke.
It works by blocking the effects of an enzyme involved in multiplication and survival of certain white blood cells called lymphocytes.
Deluje tako, da zavre učinek encima, ki sodeluje pri razmnoževanju in preživetju nekaterih belih krvnih celic, imenovanih limfociti.
Blood tests may also show: • increased blood levels of liver enzymes
Krvne preiskave lahko pokažejo tudi: • povečanje ravni jetrnih encimov v krvi
Study 101-08/99 enrolled 64 subjects with previously untreated CLL, including 5 subjects with small lymphocytic lymphoma (SLL).
V študijo 101-08/99 je bilo vključenih 64 oseb s predhodno nezdravljenim KLL, vključno s 5 osebami z limfomom majhnih limfocitov (SLL-small lymphocytic lymphoma).
↑ serum concentrations Caution should be exercised and patients closely observed for bosentan-related toxicity.
↑ koncentracij v serumu Potrebna je previdnost, bolnike pa je treba skrbno spremljati zaradi toksičnosti, povezane z bosentanom.
If the benefits of resuming idelalisib are judged to outweigh the risks, consideration should be given to administering pre-emptive CMV therapy.
Če je ocenjeno, da bi bile koristi nadaljevanja zdravljenja z idelalizibom večje od tveganj, je treba razmisliti o izvedbi predbolezenskega zdravljenja CMV.
There is insufficient data to make dose recommendations for patients with severe hepatic impairment.
Ni dovolj podatkov za priporočila pri bolnikih s hudo jetrno okvaro.
Treatment may be resumed at a lower dose once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN).
Z zdravljenjem se lahko nadaljuje z nižjim odmerkom, ko se vrednosti vrnejo na 1. stopnjo ali nižje (ALT/AST ≤ 3 x ULN).
If you forget to take Zydelig
Če ste pozabili vzeti zdravilo Zydelig
61.2 (38.1, NR)
61,2 (38,1; ND)
BCRP, OATP1B1, OATP1B3 and P-gp substrates
Substrati BCRP, OATP1B1, OATP1B3 in P-gp
Idelalisib has not been studied in patients with chronic active hepatitis including viral hepatitis.
Idelaliziba niso preučili pri bolnikih s kroničnim aktivnim hepatitisom, vključno z virusnim hepatitisom.
• rifabutin, a medicine used to treat bacterial infections including tuberculosis
• rifabutin, zdravilo, ki se uporablja za zdravljenje bakterijskih okužb, vključno s tuberkulozo
The European Medicines Agency has deferred the obligation to submit the results of studies with idelalisib in one or more subsets of the paediatric population in the treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z idelalizibom za eno ali več podskupin pediatrične populacije za zdravljenje novotvorb zrelih celic B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
A risk for P-gp inhibition in the gastrointestinal tract, that could result in increased exposure of sensitive substrates for intestinal P-gp such as dabigatran etexilate, cannot be excluded.
Tveganja za zaviranje P-gp v prebavilih, ki bi lahko povzročilo večjo izpostavljenost substratov, občutljivih za črevesni P-gp, kot je dabigatran eteksilat, ni mogoče izključiti.
In FL Zydelig is used on its own in patients whose cancer has not responded to treatment with two previous cancer treatments.
Pri FL se zdravilo Zydelig uporablja samo pri bolnikih, katerih rak se na dve predhodni zdravljenji proti raku ni odzval.
P-value
vrednost p
Zydelig may be prescribed in combination with other medicines for the treatment of CLL.
Zdravilo Zydelig se lahko predpiše v kombinaciji z drugimi zdravili za zdravljenje KLL.
If either moderate or severe symptomatic pneumonitis or organising pneumonia is diagnosed, appropriate treatment should be initiated and idelalisib must be permanently discontinued.
Če se vzpostavi diagnoza zmernega ali hudega simptomatskega pnevmonitisa ali organizirajoče pljučnice, je treba uvesti ustrezno zdravljenje in trajno prekiniti uporabo idelaliziba.
Patients should be monitored for respiratory signs and symptoms throughout treatment.
Pri bolnikih je treba ves čas zdravljenja spremljati respiratorne znake in simptome.
Patients with CMV viraemia without associated clinical signs of CMV infection should be carefully monitored.
Bolnike z viremijo CMV brez povezanih kliničnih znakov okužbe s CMV je treba natančno spremljati.
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.
Pri pojavu povečanja vrednosti ALT in/ali AST 2. ali višje stopnje je treba spremljati bolnikove vrednosti ALT, AST in skupnega bilirubina vsak teden, dokler se vrednosti ne vrnejo na 1. ali nižjo stopnjo.
Overall iNHL cohort (N=125) n (%)
Celokupna kohorta iNHL (N = 125) n (%)
The duration of post-treatment prophylaxis should be based on clinical judgment and may take into account a patient's risk factors such as concomitant corticosteroid treatment and prolonged neutropenia (see section 4.8).
Trajanje profilakse po zdravljenju mora biti odvisno od zdravniške presoje in lahko upošteva dejavnike tveganja bolnika, kot sta sočasno zdravljenje s kortikosteroidi in dolgotrajna nevtropenija (glejte poglavje 4.8).
In vitro interaction data
Podatki o medsebojnem delovanju in vitro
There have also been reports of hepatocellular injury including hepatic failure.
Poročali so tudi o hepatocelularnih poškodbah, vključno z odpovedjo jeter.
The primary endpoint was the ORR defined as the proportion of subjects who achieved a CR or PR (based on the Revised Response Criteria for Malignant Lymphoma [Cheson]), and, for subjects with Waldenström macroglobulinaemia, a minor response (MR) (based on the Response Assessment for Waldenström macroglobulinaemia [Owen]).
Primarni opazovani dogodek je bila vrednost ORR, opredeljena kot delež oseb, ki je dosegel CR ali PR (na podlagi Revidiranih kriterijev odziva za maligni limfom-Revised Response Criteria for Malignant Lymphoma [Cheson]), in, za osebe z Waldenströmovo makroglobulinemijo, manjši odziv (MR-minor response) (na podlagi Ocene odziva za Waldenströmovo makroglobulinemijo-Response Assessment for Waldenström macroglobulinaemia [Owen]).
Intensified monitoring of adverse reactions is recommended in patients with impaired hepatic function as exposure is expected to be increased in this population, in particular in patients with severe hepatic impairment.
Pri bolnikih z okvarjenim delovanjem jeter se priporoča intenzivnejše spremljanje neželenih učinkov, saj je pričakovati, da bo izpostavljenost pri teh bolnikih povečana, zlasti pri bolnikih s hudo jetrno okvaro.
Treatment with Zydelig should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection.
Zdravljenja z zdravilom Zydelig se ne sme uvesti pri bolnikih s kakršnimi koli znaki prisotne sistemske bakterijske, glivične ali virusne okužbe.
The major metabolite, GS-563117, may enhance phototoxicity when cells are simultaneously exposed to UVA light.
Glavni presnovek, GS-563117, lahko okrepi fototoksičnost, ko so celice hkrati izpostavljene UVA svetlobi.
If PML is suspected then appropriate diagnostic evaluations should be undertaken and treatment suspended until PML is excluded.
Če obstaja sum, da je prisotna PML, so potrebne ustrezne diagnostične ocene in prekinitev zdravljenja, dokler se PML ne izključi.
Of the 53 subjects who did not respond, 41 (32.8%) had stable disease, 10 (8.0%) had progressive disease, and 2 (1.6%) were not evaluable.
Med 53 osebami, ki se niso odzvale, jih je imelo 41 (32,8 %) stabilno bolezen, 10 (8,0 %) napredovalo bolezen, 2 (1,6 %) pa ni bilo mogoče oceniti.
• pimozide, a medicine used to treat abnormal thoughts or feelings
• pimozid; zdravilo, ki se uporablja za zdravljenje nenormalnih misli ali občutkov
Unchanged idelalisib accounted for 23% of total radioactivity recovered in urine over 48 hours and 12% of total radioactivity recovered in faeces over 144 hours.
Nespremenjeni idelalizib je predstavljal 23 % skupne radioaktivnosti, izločene v urinu v 48-urnem obdobju, in 12 % skupne radioaktivnosti, izločene v blatu v 144-urnem obdobju.
Potential interactions between idelalisib and co-administered medicinal products that are CYP3A substrates are listed in Table 1 (increase is indicated as “↑”).
Možna medsebojna delovanja idelaliziba in sočasno dajanih zdravil, ki so substrati CYP3A, so našteta v preglednici 1 (povečanje je označeno z "↑").
Electrocardiographic
Elektrokardiografični
Only subjects that had both baseline and ≥ 1 evaluable post-baseline assessments were included in this analysis.
V to analizo so bile vključene le osebe, ki so imele oceno ob izhodišču in ≥ 1 oceno po izhodišču, ki jo je bilo mogoče oceniti.
Do not stop taking Zydelig
Ne prenehajte jemati zdravila Zydelig
Adverse reactions are listed by system organ class and frequency.
Neželeni učinki so našteti po organskih sistemih in pogostnostjo.
Degeneration of the seminiferous tubules in the testes was observed in 2- to 13-week repeated dose studies in dogs and rats, but not in studies of 26 weeks and longer duration.
Degeneracije semenskih kanalov v modih so pri psih in podganah opazili v študijah s ponavljajočimi odmerki, ki so trajale od 2 do 13 tednov, ne pa tudi v študijah, ki so trajale 26 tednov ali dlje.
In vitro, idelalisib both inhibited and induced CYP2C8, but it is not known whether this translates to an in vivo effect on CYP2C8 substrates.
In vitro je idelalizib zaviral in induciral CYP2C8, vendar ni znano, ali to velja tudi za učinek in vivo na substrate CYP2C8.
If you miss a dose by more than 6 hours, wait and take the next dose at your usual time.
Če odmerek izpustite za več kot 6 ur, počakajte in vzemite naslednji odmerek ob običajnem času.
Effects on embryo-foetal development were not investigated in a second species.
Učinkov na razvoj zarodka in ploda niso preučili pri drugih živalskih vrstah.
• cisapride, a medicine used to relieve certain stomach problems
• cisaprid; zdravilo, ki se uporablja za lajšanje nekaterih želodčnih težav
Because this enzyme is overactivated in certain cancerous white blood cells, by blocking it, Zydelig will kill and reduce the number of cancer cells.
Pri nekaterih rakavih belih krvnih celicah je ta encim preveč aktiven, zato z zaviranjem tega encima zdravilo Zydelig ubije in zmanjša število rakavih celic.
Efficacy results are summarised in Tables 3 and 4.
Rezultati učinkovitosti so povzeti v preglednicah 3 in 4.
< 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from available data).
< 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
No patients with severe hepatic impairment were included in clinical studies of idelalisib.
Bolniki s hudo jetrno okvaro niso bili vključeni v klinične študije idelaliziba.
Efficacy results are summarised in Table 7.
Rezultati učinkovitosti so povzeti v preglednici 7.
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.
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.
Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4).
Ena tableta vsebuje 0,1 mg barvila sončno rumeno FCF (E110) (glejte poglavje 4.4).
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
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.
Subjects received 150 mg of idelalisib orally twice daily until evidence of disease progression or unacceptable toxicity.
Osebe so prejemale 150 mg idelaliziba peroralno dvakrat na dan do dokazanega napredovanja bolezni ali nesprejemljive toksičnosti.
Rash typically resolved with treatment (e.g., topical and/or oral steroids, diphenhydramine) and dose interruption for severe cases (see section 5.3, phototoxicity).
Običajno je izpuščaj izzvenel z zdravljenjem (npr. topikalni in/ali peroralni steroidi, difenhidramin) in prekinitvijo odmerjanja v hudih primerih (glejte poglavje 5.3, fototoksičnost).
In patients presenting with serious lung events, idelalisib should be interrupted and the patient assessed for an explanatory aetiology.
Pri bolnikih z resnimi pljučnimi dogodki je treba uporabo idelaliziba prekiniti in bolnika oceniti za obrazložitveno etiologijo.
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).
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).
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.
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.
The primary endpoint was progression free survival (PFS).
Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS-progression free survival).
Zydelig is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravila Zydelig ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Pneumonitis and organising pneumonia
Pnevmonitis in organizirajoča pljučnica
Infections and infestations Infections (including Pneumocystis jirovecii pneumonia and CMV)*
Infekcijske in parazitske bolezni okužbe (vključno s pljučnico, povzročeno s Pneumocystis jirovecii, in okužbo s CMV)*
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.
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.
^ 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.
^ 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).
Elevated liver transaminases
Povečanje jetrnih transaminaz
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.
Po uporabi idelaliziba so poročali o primerih progresivne multifokalne levkoencefalopatije (PML) ob predhodnem ali sočasnem zdravljenju z imunosupresivi, ki so povezani s PML.
Amlodipine, diltiazem, felodipine, nifedipine, nicardipine
amlodipin, diltiazem, felodipin, nifedipin, nikardipin
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).
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).
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.
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.
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.
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).
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.
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.
Clinical monitoring is recommended.
Priporoča se klinično spremljanje.
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.
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.
Idelalisib was taken until disease progression or unacceptable toxicity.
Idelalizib se je jemal do napredovanja bolezni ali nesprejemljive toksičnosti.
What Zydelig looks like and contents of the pack
Izgled zdravila Zydelig in vsebina pakiranja
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]).
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]).
• trazodone, a medicine used to treat depression
• trazodon, zdravilo, ki se uporablja za zdravljenje depresije
↑ serum concentrations Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.
↑ koncentracij v serumu Priporoča se skrbno titriranje odmerka antidepresiva in spremljanje odziva na antidepresiv.
Animal studies indicate the potential for harmful effects of idelalisib on fertility and foetal development (see section 5.3).
Študije na živalih kažejo na možne škodljive učinke idelaliziba na plodnost in razvoj zarodka (glejte poglavje 5.3).
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.
Smatrajo, da prilagoditev začetnega odmerka idelaliziba pri sočasnem dajanju z zaviralci CYP3A/P-gp ni potrebna, vendar se priporoča intenzivnejše spremljanje neželenih učinkov.
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.
Ocenitev potenciala za fototoksičnost v embrionski celični liniji fibroblastov miši BALB/c 3T3 za idelalizib ni bila sklepčna zaradi citotoksičnosti testa in vitro.
If you miss a dose by less than 6 hours, take the missed dose right away.
Če odmerek izpustite za manj kot 6 ur, takoj vzemite izpuščeni odmerek.
• midazolam, triazolam, when taken by mouth to help you sleep and/or relieve anxiety
• midazolam, triazolam; kadar se uporabljata peroralno kot pomoč pri spanju in/ali za lajšanje tesnobe