FrancophonIA/ELRC3.0 huggingface dataset:
English: It is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method as a second form of contraception.
Slovenian: Trenutno ni znano, ali lahko idelalizib zmanjša učinkovitost hormonskih kontraceptivov, zato morajo ženske, ki uporabljajo hormonske kontraceptive, dodati pregradno metodo kot drugo obliko kontracepcije.
English: Idelalisib is not considered to have broad immunosuppressive activity.
Slovenian: Smatrajo, da idelalizib nima široke imunosupresivne aktivnosti.
English: If you are currently breast-feeding, talk to your doctor before starting treatment.
Slovenian: Če trenutno dojite, se pred začetkom zdravljenja pogovorite z zdravnikom.
English: This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
Slovenian: Ta opažena limfocitoza je farmakodinamični učinek in naj se brez prisotnosti drugih kliničnih rezultatov ne šteje za progresivno bolezen.
English: The median OS, including long-term follow-up for all FL subjects was 61.2 months.
Slovenian: Mediani čas OS, vključno z dolgoročnim spremljanjem vseh oseb s FL, je bil 61,2 meseca.
English: Concentration monitoring of sedatives/hypnotics is recommended and dose reduction may be considered.
Slovenian: Priporoča se spremljanje koncentracij sedativov/hipnotikov in razmisli se lahko o zmanjšanju odmerka.
English: This is to check that you do not have an infection, that your liver is working properly, and that your blood counts are normal.
Slovenian: Z njimi bodo preverjali, ali imate morda kakšno okužbo, ali jetra pravilno delujejo in ali imate normalno krvno sliko.
English: • if you have shortness of breath or difficulty breathing
Slovenian: • če imate kratko sapo ali težave z dihanjem.
English: Alternatively, switching to pravastatin, rosuvastatin, or pitavastatin may be considered.
Slovenian: Alternativno se lahko razmisli o prehodu na pravastatin, rosuvastatin ali pitavastatin.
English: • Zydelig may make the contraceptive “pill” and implanted hormonal contraceptives work less well.
Slovenian: • Zaradi zdravila Zydelig lahko postanejo kontracepcijska "tabletka" in vsajeni hormonski kontraceptivi manj učinkoviti.
English: Women using hormonal contraceptives should add a barrier method as a second form of contraception since it is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives.
Slovenian: Ženske, ki uporabljajo hormonske kontraceptive, morajo dodati pregradno metodo kot drugo obliko kontracepcije, saj trenutno ni znano, ali lahko idelalizib zmanjša učinkovitost hormonskih kontraceptivov.
English: The following pack size is available: outer carton containing 1 plastic bottle of 60 film-coated tablets.
Slovenian: Na voljo je naslednja velikost pakiranja: zunanja škatla, ki vsebuje 1 plastenko s 60 filmsko obloženimi tabletami.
English: For subjects in the placebo + R group, the summary includes data up to the first dosing of idelalisib in an extension study.
Slovenian: Za osebe v skupini placebo + R vključuje povzetek podatke do prvega odmerjanja idelaliziba v podaljšani študiji.
English: There have been cases of PJP after stopping idelalisib treatment.
Slovenian: Obstajajo primeri PJP po prenehanju zdravljenja z idelalizibom.
English: Your doctor will check your blood counts before or during treatment with Zydelig and in rare cases they may need to give you another medicine.
Slovenian: Vaš zdravnik bo preveril vaše krvne vrednosti pred zdravljenjem z zdravilom Zydelig in med njim; v redkih primerih vam bo morda moral dati drugo zdravilo.
English: Subjects had a median Cumulative Illness Rating Scale (CIRS) score of 8.
Slovenian: Osebe so imele mediani rezultat skupne ocene bolezni (CIRS-Cumulative Illness Rating Scale) 8.
English: In vitro, the CYP3A4 inhibition was irreversible, and return to normal enzyme activity is therefore expected to take several days after stopping idelalisib administration.
Slovenian: In vitro je bilo zaviranje CYP3A4 ireverzibilno, zato se pričakuje, da bo vrnitev na normalno encimsko aktivnost trajala več dni po prenehanju dajanja idelaliziba.
English: Women of childbearing potential / contraception
Slovenian: Ženske v rodni dobi / kontracepcija
English: Severe skin blistering conditions have been reported in some people who have received Zydelig while also receiving other medicines known to cause these potentially life-threatening conditions.
Slovenian: Poročali so o stanjih s hudimi kožnimi mehurji pri nekaterih ljudeh, ki so prejemali zdravilo Zydelig sočasno z drugimi zdravili, za katera je znano, da povzročajo ta življenjsko ogrožajoča stanja.
English: Clinical monitoring is recommended and a lower starting dose of atorvastatin may be considered.
Slovenian: Priporoča se klinično spremljanje in lahko se razmisli o nižjem začetnem odmerku atorvastatina.
English: Nearly all PJP infections, including fatal cases, occurred in the absence of PJP prophylaxis.
Slovenian: Skoraj do vseh okužb s PJP, vključno s smrtnimi primeri, je prišlo ob odsotnosti profilakse za PJP.
English: Reproductive and developmental toxicity
Slovenian: Toksičnost za razmnoževanje in razvoj
English: The plasma exposures (Cmax and AUC) of idelalisib are approximately dose proportional between 50 mg and 100 mg and less than dose proportional above 100 mg.
Slovenian: Izpostavljenosti idelalizibu v plazmi (Cmax in AUC) sta približno sorazmerni z odmerkom med 50 mg in 100 mg in manj kot sorazmerni z odmerkom nad 100 mg.
English: In CLL Zydelig treatment is used in combination with another medicine (rituximab) in patients who have certain high-risk factors or in patients whose cancer has come back after at least one previous treatment.
Slovenian: Pri KLL se zdravljenje z zdravilom Zydelig uporablja v kombinaciji z drugim zdravilom (rituksimab), pri bolnikih, ki imajo nekatere dejavnike velikega tveganja, ali pri bolnikih, pri katerih se je rak po vsaj enem predhodnem zdravljenju ponovil.
English: • Tell your doctor immediately if you become pregnant.
Slovenian: • Zdravnika takoj obvestite, če zanosite.
English: Increases in liver transaminases were generally observed within the first 12 weeks of treatment, and were reversible with dose interruption (see section 4.2).
Slovenian: Povišanje jetrnih transaminaz so običajno opazili v prvih 12 tednih zdravljenja in je bilo reverzibilno po prekinitvi odmerjanja (glejte poglavje 4.2).
English: 26% had recurrence of ALT/AST elevation.
Slovenian: Povišanje ravni ALT/AST se je ponovno pojavilo pri 26 %
English: • as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).
Slovenian: • kot zdravilo prve izbire ob prisotnosti delecije 17p ali mutacije TP53 pri bolnikih, za katere ni primerno nobeno drugo zdravljenje (glejte poglavje 4.4).
English: At a dose 2.7 times the maximum recommended dose, idelalisib did not prolong the QT/QTc interval (i.e.,< 10 ms).
Slovenian: Pri 2,7-krat večjem odmerku od največjega priporočenega odmerka idelalizib ni podaljšal intervala QT/QTc (tj.< 10 ms).
English: Zydelig can be taken with or without food.
Slovenian: Zdravilo Zydelig se lahko jemlje s hrano ali brez nje.
English: Rash was generally mild to moderate and resulted in discontinuation of treatment in 2.1% of subjects.
Slovenian: Izpuščaj je bil na splošno blag do zmeren in je povzročil prekinitev zdravljenja pri 2,1 % osebah.
English: Contact your doctor or nearest emergency department immediately for advice.
Slovenian: Takoj se posvetujte z zdravnikom ali pojdite na urgentni oddelek najbližje bolnišnice.
English: Idelalisib is 93% to 94% bound to human plasma proteins at concentrations observed clinically.
Slovenian: Idelalizib se pri klinično opaženih koncentracijah 93 % do 94 % veže na beljakovine v človeški plazmi.
English: In many instances the pathogen was not identified; however, both conventional and opportunistic pathogens, including PJP and CMV, were among those identified.
Slovenian: V mnogih primerih patogen ni bil prepoznan, vendar pa so bili med prepoznanimi patogeni tako konvencionalni kot oportunistični patogeni, vključno s PJP in CMV.
English: Taking Zydelig with certain medicines may stop them working properly, or may make side effects worse.
Slovenian: Jemanje zdravila Zydelig z nekaterimi zdravili lahko povzroči, da ta zdravila morda ne bodo pravilno delovala ali pa se bodo neželeni učinki okrepili.
English: Cases of severe drug-related colitis occurred relatively late (months) after the start of therapy, sometimes with rapid aggravation, but resolved within a few weeks with dose interruption and additional symptomatic treatment (e.g., anti-inflammatory agents such as enteric budesonide).
Slovenian: Primeri hudega z zdravilom povezanega kolitisa so se pojavili relativno pozno (mesece) po začetku zdravljenja, včasih s hitrim poslabšanjem, vendar so minili v nekaj tednih po prekinitvi odmerjanja in dodatnem simptomatskem zdravljenju (npr. zdravila proti vnetju, kot je enterični budezonid).
English: ALPHA-1 ADRENORECEPTOR ANTAGONISTS
Slovenian: ANTAGONISTI ADRENORECEPTORJEV ALFA 1 alfuzosin
English: All subjects were refractory to rituximab and 124 of 125 subjects were refractory to at least one alkylating agent.
Slovenian: Vse osebe so bile neodzivne na rituksimab, 124 od 125 oseb pa je bilo neodzivnih na vsaj eno od alkilirajočih zdravil.
English: Of the 125 subjects enrolled, 80 (64%) were male, the median age was 64 years (range: 33 to 87), and 110 (89%) were white.
Slovenian: 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.
English: Zydelig has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Zydelig nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Treatment with Zydelig should be conducted by a physician experienced in the use of anti-cancer therapies.
Slovenian: Zdravljenje z zdravilom Zydelig mora voditi zdravnik z izkušnjami pri uporabi zdravil proti raku.
English: 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.
Slovenian: 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.
English: • if you have liver problems
Slovenian: • če imate težave z jetri,
English: Idelalisib induced inflammatory changes in both rats and dogs.
Slovenian: Idelalizib je povzročil vnetne spremembe pri podganah in psih.
English: Blood tests may also show: • increased blood levels of fats
Slovenian: Krvne preiskave lahko pokažejo tudi: • povečanje ravni maščob v krvi
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
Slovenian: Kombinacija lahko povzroči večje tveganje za kardiovaskularne neželene učinke, povezane s salmeterolom, vključno s podaljšanjem QT, palpitacijami in sinusno tahikardijo.
English: The onset of isolated lymphocytosis typically occurs during the first 2 weeks of idelalisib therapy and is often associated with reduction of lymphadenopathy.
Slovenian: Izolirana limfocitoza se tipično pojavi v prvih 2 tednih prejemanja terapije idelaliziba in je pogosto povezana z znižanjem limfadenopatije.
English: 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.
Slovenian: Faze (študiji 312-0116 in študiji 312-0119) in šestih študijah 1. in 2. faze.
English: Co-administration of idelalisib with CYP3A substrates may increase their systemic exposures and increase or prolong their therapeutic activity and adverse reactions.
Slovenian: Sočasno dajanje idelaliziba s substrati CYP3A lahko poveča njihovo sistemsko izpostavljenost in poveča ali podaljša njihovo terapevtsko aktivnost in neželene učinke.
English: It works by blocking the effects of an enzyme involved in multiplication and survival of certain white blood cells called lymphocytes.
Slovenian: Deluje tako, da zavre učinek encima, ki sodeluje pri razmnoževanju in preživetju nekaterih belih krvnih celic, imenovanih limfociti.
English: Blood tests may also show: • increased blood levels of liver enzymes
Slovenian: Krvne preiskave lahko pokažejo tudi: • povečanje ravni jetrnih encimov v krvi
English: Study 101-08/99 enrolled 64 subjects with previously untreated CLL, including 5 subjects with small lymphocytic lymphoma (SLL).
Slovenian: 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).
English: Sildenafil, tadalafil
Slovenian: sildenafil tadalafil sildenafil, tadalafil
English: ↑ serum concentrations Caution should be exercised and patients closely observed for bosentan-related toxicity.
Slovenian: ↑ koncentracij v serumu Potrebna je previdnost, bolnike pa je treba skrbno spremljati zaradi toksičnosti, povezane z bosentanom.
English: If the benefits of resuming idelalisib are judged to outweigh the risks, consideration should be given to administering pre-emptive CMV therapy.
Slovenian: Če je ocenjeno, da bi bile koristi nadaljevanja zdravljenja z idelalizibom večje od tveganj, je treba razmisliti o izvedbi predbolezenskega zdravljenja CMV.
English: There is insufficient data to make dose recommendations for patients with severe hepatic impairment.
Slovenian: Ni dovolj podatkov za priporočila pri bolnikih s hudo jetrno okvaro.
English: Treatment may be resumed at a lower dose once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN).
Slovenian: Z zdravljenjem se lahko nadaljuje z nižjim odmerkom, ko se vrednosti vrnejo na 1. stopnjo ali nižje (ALT/AST ≤ 3 x ULN).
English: If you forget to take Zydelig
Slovenian: Če ste pozabili vzeti zdravilo Zydelig
English: 61.2 (38.1, NR)
Slovenian: 61,2 (38,1; ND)
English: BCRP, OATP1B1, OATP1B3 and P-gp substrates
Slovenian: Substrati BCRP, OATP1B1, OATP1B3 in P-gp
English: Idelalisib has not been studied in patients with chronic active hepatitis including viral hepatitis.
Slovenian: Idelaliziba niso preučili pri bolnikih s kroničnim aktivnim hepatitisom, vključno z virusnim hepatitisom.
English: • rifabutin, a medicine used to treat bacterial infections including tuberculosis
Slovenian: • rifabutin, zdravilo, ki se uporablja za zdravljenje bakterijskih okužb, vključno s tuberkulozo
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: In FL Zydelig is used on its own in patients whose cancer has not responded to treatment with two previous cancer treatments.
Slovenian: Pri FL se zdravilo Zydelig uporablja samo pri bolnikih, katerih rak se na dve predhodni zdravljenji proti raku ni odzval.
English: P-value
Slovenian: vrednost p
English: Zydelig may be prescribed in combination with other medicines for the treatment of CLL.
Slovenian: Zdravilo Zydelig se lahko predpiše v kombinaciji z drugimi zdravili za zdravljenje KLL.
English: If either moderate or severe symptomatic pneumonitis or organising pneumonia is diagnosed, appropriate treatment should be initiated and idelalisib must be permanently discontinued.
Slovenian: Če se vzpostavi diagnoza zmernega ali hudega simptomatskega pnevmonitisa ali organizirajoče pljučnice, je treba uvesti ustrezno zdravljenje in trajno prekiniti uporabo idelaliziba.
English: Patients should be monitored for respiratory signs and symptoms throughout treatment.
Slovenian: Pri bolnikih je treba ves čas zdravljenja spremljati respiratorne znake in simptome.
English: Patients with CMV viraemia without associated clinical signs of CMV infection should be carefully monitored.
Slovenian: Bolnike z viremijo CMV brez povezanih kliničnih znakov okužbe s CMV je treba natančno spremljati.
English: 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.
Slovenian: 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.
English: Overall iNHL cohort (N=125) n (%)
Slovenian: Celokupna kohorta iNHL (N = 125) n (%)
English: 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).
Slovenian: 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).
English: In vitro interaction data
Slovenian: Podatki o medsebojnem delovanju in vitro
English: There have also been reports of hepatocellular injury including hepatic failure.
Slovenian: Poročali so tudi o hepatocelularnih poškodbah, vključno z odpovedjo jeter.
English: 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]).
Slovenian: 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]).
English: 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.
Slovenian: 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.
English: Treatment with Zydelig should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal, or viral infection.
Slovenian: Zdravljenja z zdravilom Zydelig se ne sme uvesti pri bolnikih s kakršnimi koli znaki prisotne sistemske bakterijske, glivične ali virusne okužbe.
English: The major metabolite, GS-563117, may enhance phototoxicity when cells are simultaneously exposed to UVA light.
Slovenian: Glavni presnovek, GS-563117, lahko okrepi fototoksičnost, ko so celice hkrati izpostavljene UVA svetlobi.
English: If PML is suspected then appropriate diagnostic evaluations should be undertaken and treatment suspended until PML is excluded.
Slovenian: Če obstaja sum, da je prisotna PML, so potrebne ustrezne diagnostične ocene in prekinitev zdravljenja, dokler se PML ne izključi.
English: 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.
Slovenian: 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.
English: • pimozide, a medicine used to treat abnormal thoughts or feelings
Slovenian: • pimozid; zdravilo, ki se uporablja za zdravljenje nenormalnih misli ali občutkov
English: 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.
Slovenian: 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.
English: Potential interactions between idelalisib and co-administered medicinal products that are CYP3A substrates are listed in Table 1 (increase is indicated as “↑”).
Slovenian: Možna medsebojna delovanja idelaliziba in sočasno dajanih zdravil, ki so substrati CYP3A, so našteta v preglednici 1 (povečanje je označeno z "↑").
English: Chronic hepatitis
Slovenian: Kronični hepatitis
English: Electrocardiographic
Slovenian: Elektrokardiografični
English: Only subjects that had both baseline and ≥ 1 evaluable post-baseline assessments were included in this analysis.
Slovenian: 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.
English: Do not stop taking Zydelig
Slovenian: Ne prenehajte jemati zdravila Zydelig
English: Adverse reactions are listed by system organ class and frequency.
Slovenian: Neželeni učinki so našteti po organskih sistemih in pogostnostjo.
English: 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.
Slovenian: 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.
English: In vitro, idelalisib both inhibited and induced CYP2C8, but it is not known whether this translates to an in vivo effect on CYP2C8 substrates.
Slovenian: In vitro je idelalizib zaviral in induciral CYP2C8, vendar ni znano, ali to velja tudi za učinek in vivo na substrate CYP2C8.
English: If you miss a dose by more than 6 hours, wait and take the next dose at your usual time.
Slovenian: Če odmerek izpustite za več kot 6 ur, počakajte in vzemite naslednji odmerek ob običajnem času.
English: Effects on embryo-foetal development were not investigated in a second species.
Slovenian: Učinkov na razvoj zarodka in ploda niso preučili pri drugih živalskih vrstah.
English: • cisapride, a medicine used to relieve certain stomach problems
Slovenian: • cisaprid; zdravilo, ki se uporablja za lajšanje nekaterih želodčnih težav
English: Because this enzyme is overactivated in certain cancerous white blood cells, by blocking it, Zydelig will kill and reduce the number of cancer cells.
Slovenian: Pri nekaterih rakavih belih krvnih celicah je ta encim preveč aktiven, zato z zaviranjem tega encima zdravilo Zydelig ubije in zmanjša število rakavih celic.
English: Efficacy results are summarised in Tables 3 and 4.
Slovenian: Rezultati učinkovitosti so povzeti v preglednicah 3 in 4.
English: < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from available data).
Slovenian: < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: No patients with severe hepatic impairment were included in clinical studies of idelalisib.
Slovenian: Bolniki s hudo jetrno okvaro niso bili vključeni v klinične študije idelaliziba.
English: Efficacy results are summarised in Table 7.
Slovenian: Rezultati učinkovitosti so povzeti v preglednici 7.