FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Študija 312-0119 je bila randomizirana, odprta, multicentrična študija 3. faze z vzporednimi skupinami, v kateri je bilo 261 oseb s predhodno zdravljeno KLL, ki so imeli izmerljivo limfadenopatijo, ki je zahtevala zdravljenje in pri katerih je KLL napredovala < 24 mesecev od končanja predhodnega zdravljenja.
English: Idelalisib can be administered without regard to food.
Slovenian: Idelalizib se lahko uporablja ne glede na hrano.
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.
Slovenian: Pri sočasni uporabi idelaliziba z drugimi zdravili je treba upoštevati povzetek glavnih značilnosti zdravila za druga zdravila glede priporočil o sočasni uporabi z zaviralci CYP3A4.
English: Particular caution must be used and dose reduction may be considered when prescribing sildenafil or tadalafil with idelalisib with increased monitoring for adverse events.
Slovenian: Pri predpisovanju sildenafila ali tadalafila z idelalizibom je potrebna posebna previdnost in razmisli se lahko o zmanjšanju odmerka s povečanim spremljanjem neželenih učinkov.
English: ANTI-CANCER AGENTS
Slovenian: ZDRAVILA PROTI RAKU
English: • alfuzosin, a medicine used to treat an enlarged prostate • dabigatran, warfarin, medicines used to thin the blood
Slovenian: • alfuzosin; zdravilo, ki se uporablja za zdravljenje povečanja prostate • dabigatran in varfarin; zdravila, ki se uporabljajo za redčenje krvi
English: Elderly No specific dose adjustment is required for elderly patients (aged ≥ 65 years) (see section 5.2).
Slovenian: Starejši bolniki Pri starejših bolnikih (starost ≥ 65 let) odmerka ni treba posebej prilagajati (glejte poglavje 5.2).
English: • if you have a new or worsening cough
Slovenian: • če se pojavi kašelj ali če se obstoječi kašelj poslabša,
English: ALT, AST, and total bilirubin must be monitored in all patients every 2 weeks for the first 3 months of treatment, then as clinically indicated.
Slovenian: Pri vseh bolnikih je treba prve 3 mesece zdravljenja vsaka 2 tedna spremljati vrednosti ALT, AST in skupnega bilirubina, nato pa kot je klinično indicirano.
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.
Slovenian: Podatki in vitro kažejo, da idelalizib ni zaviralec presnovnih encimov CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A ali UGT1A1 ali prenašalcev OAT1, OAT3 ali OCT2.
English: Carbamazepine
Slovenian: karbamazepin
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.
Slovenian: Vrednost ORR je bila 96,9 %, z 12 CR (18,8 %) in 50 PR (78,1 %), vključno s 3 CR in 6 PR pri osebah z delecijo 17p in/ali mutacijo TP53, ter 2 CR in 34 PR pri osebah z nemutiranim IGHV.
English: Common * Comprised of opportunistic infections as well as bacterial and viral infections such as pneumonia, bronchitis, and sepsis.
Slovenian: Preiskave povečanje trigliceridov zelo pogosti pogosti * Obsega oportunistične okužbe ter bakterijske in virusne okužbe, kot so pljučnica, bronhitis in sepsa.
English: • if you have swelling and blistering of the lining of the mouth, genitals, and/or eyes
Slovenian: • če imate oteklo in mehurjasto ustno sluznico, spolovila in/ali oči.
English: • buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
Slovenian: • buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem, zdravila, ki se uporabljajo za zdravljenje motenj živčnega sistema
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.
Slovenian: V klinični študiji medsebojnega delovanja zdravil so ugotovili, da je sočasno dajanje enega odmerka 150 mg idelaliziba z rifampicinom (močan induktor CYP3A) povzročilo ~75-odstotno zmanjšanje AUCinf idelaliziba.
English: INHALED BETA AGONIST
Slovenian: INHALIRANI AGONISTI BETA salmeterol
English: DOR (months) median (95% CI) PFS (months) median (95% CI) OS (months) median (95% CI)
Slovenian: DOR (meseci) mediana (95-odstotni IZ) PFS (meseci) mediana (95-odstotni IZ) OS (meseci) median (95-odstotni IZ)
English: In patients who resumed idelalisib at a lower dose,
Slovenian: bolnikov, ki so ponovno začeli jemati idelalizib z nižjim odmerkom.
English: Do not chew or crush the tablet.
Slovenian: Tablete ne žvečite ali drobite.
English: Table 3: Efficacy results from study 312-0116 Idelalisib + R N = 110
Slovenian: Preglednica 3: Rezultati učinkovitosti iz študije 312-0116 Idelalizib + R
English: Caution is recommended when administering Zydelig in this population.
Slovenian: Pri dajanju zdravila Zydelig tej populaciji se priporoča previdnost.
English: Subjects were randomised 2:1 to receive idelalisib 150 mg twice daily and 12 infusions of ofatumumab over 24 weeks, or 12 infusions of ofatumumab only over 24 weeks.
Slovenian: Osebe so bile randomizirane v razmerju 2 : 1 v skupino, ki je prejemala idelalizib 150 mg dvakrat na dan in 12 infundiranj ofatumumaba v 24-tedenskem obdobju, ali skupino, ki je prejela samo 12 infundiranj ofatumumaba v 24-tedenskem obdobju.
English: Clarithromycin, telithromycin ↑ serum concentrations No dose adjustment of clarithromycin is required for patients with normal renal function or mild renal impairment (creatinine clearance [CrCl] 60-90 mL/min).
Slovenian: ↑ koncentracij v serumu Pri bolnikih z normalnim delovanjem ledvic ali blago ledvično okvaro (očistek kreatinina [CrCl-creatinine clearance] 60-90 ml/min) prilagoditev odmerka klaritromicina ni potrebna.
English: ORR (95% CI)
Slovenian: ORR (95-odstotni IZ)
English: • budesonide, fluticasone, medicines used to treat hayfever and asthma, and salmeterol, used to treat asthma
Slovenian: • budezonid, flutikazon, zdravili, ki se uporabljata za zdravljenje senenega nahoda in astme, in salmeterol, ki se uporablja za zdravljenje astme
English: 19.4 (13.9, NR)
Slovenian: 19,4 (13,9, ND)
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).
Slovenian: Pri uvedbi zdravljenja z zdravilom Zydelig pri bolnikih z blago ali zmerno jetrno okvaro odmerka ni treba prilagajati, vendar se priporoča intenzivnejše spremljanje neželenih učinkov (glejte poglavji 4.4 in 5.2).
English: Maintain Zydelig dosing.
Slovenian: Vzdržujte odmerjanje zdravila Zydelig.
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.
Slovenian: Seznam neželenih učinkov v obliki preglednice Neželeni učinki zdravila, o katerih so poročali z idelalizibom samim ali v kombinaciji z monoklonskimi protitelesi proti CD20 (rituksimabom ali ofatumumabom), so navedeni v preglednici 2.
English: • dihydroergotamine, ergotamine, medicines used to treat migraine headache
Slovenian: • dihidroergotamin, ergotamin; zdravili, ki se uporabljata za zdravljenje glavobola zaradi migrene
English: Contains sunset yellow FCF (E110), see leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje sončno rumeno FCF (E110), za nadaljnje informacije glejte navodilo za uporabo.
English: • amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
Slovenian: • amlodipin, diltiazem, felodipin, nikardipin, nifedipin, zdravila, ki se uporabljajo za zdravljenje visokega krvnega tlaka ali težav s srcem
English: Interrupt Zydelig dosing.
Slovenian: Prekinite odmerjanje zdravila Zydelig.
English: Breast-feeding should be discontinued during treatment with Zydelig.
Slovenian: Med zdravljenjem z zdravilom Zydelig je treba prenehati z dojenjem.
English: Response category*† CR
Slovenian: 95-odstotni IZ Kategorija odziva*† CR
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and UGT1A4.
Slovenian: Idelalizib se primarno presnavlja s pomočjo aldehidne oksidaze in v manjšem obsegu s pomočjo CYP3A in UGT1A4.
English: • inflammation of the lungs
Slovenian: • vnetje pljuč
English: NR (12.3, NR)
Slovenian: ND (12,3; ND)
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation (UGT1A4).
Slovenian: Idelalizib se primarno presnavlja s pomočjo aldehidne oksidaze in v manjšem obsegu s pomočjo CYP3A in glukuronidacije (UGT1A4).
English: Treatment with Zydelig must be withheld in the event of suspected pneumonitis.
Slovenian: Zdravljenje z zdravilom Zydelig je treba pri sumu na pnevmonitis začasno ustaviti.
English: Diarrhoea/colitis
Slovenian: Driska/kolitis
English: No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
Slovenian: Pri bolnikih z blago, zmerno ali hudo ledvično okvaro odmerka ni treba prilagajati (glejte poglavje 5.2).
English: The primary endpoint was PFS. Efficacy results are summarised in Tables 5 and 6.
Slovenian: Rezultati učinkovitosti so povzeti v preglednicah 5 in 6.
English: Prophylaxis for PJP should therefore be administered to all patients throughout idelalisib treatment, and for a period of 2 to 6 months after discontinuation.
Slovenian: Ves čas zdravljenja z idelalizibom in v obdobju 2 do 6 mesecev po prekinitvi zdravljenja je treba vsem bolnikom dajati profilakso za PJP.
English: ↑ serum concentrations Clinical monitoring of therapeutic effect and adverse reactions is recommended.
Slovenian: ↑ koncentracij v serumu Priporoča se klinično spremljanje terapevtskega učinka in neželenih učinkov.
English: Women should avoid becoming pregnant while taking Zydelig, and for up to 1 month after ending treatment.
Slovenian: Ženske med jemanjem zdravila Zydelig in še 1 mesec po prenehanju zdravljenja ne smejo zanositi.
English: ↑ serum concentrations Increased monitoring for rifabutinassociated adverse reactions including neutropenia and uveitis is recommended.
Slovenian: ↑ koncentracij v serumu Priporoča se povečano spremljanje neželenih učinkov rifabutina, vključno z nevtropenijo in uveitisom.
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.
Slovenian: Po enem 150 mg odmerku pri osebah s hudo ledvično okvaro v primerjavi z zdravimi osebami niso opazili klinično pomembnih sprememb v izpostavljenosti idelalizibu ali GS-563117.
English: Study 312-0116 was a Phase 3, randomised, double-blind, placebo-controlled study in 220 subjects with previously treated CLL who required treatment but were not considered suitable for cytotoxic chemotherapy.
Slovenian: Študija 312-0116 je bila randomizirana, dvojno slepa, s placebom kontrolirana študija 3. faze, ki je zajela 220 oseb s predhodno zdravljeno KLL, ki jih je bilo treba zdraviti, a niso bili primerni za citotoksično kemoterapijo.
English: Treatment-emergent Grade 3 or 4 neutropenia, including febrile neutropenia, have occurred in patients treated with idelalisib.
Slovenian: Pri bolnikih, ki so se zdravili z idelalizibom, se je med zdravljenjem pojavila nevtropenija 3. ali 4. stopnje, vključno s febrilno nevtropenijo.
English: 20.8 (14.8, NR)
Slovenian: 20,8 (14,8; ND)
English: • diarrhoea/inflammation of the large intestine
Slovenian: • driska/vnetje debelega črevesja
English: There is very limited experience from the treatment of patients with a history of inflammatory bowel disease.
Slovenian: Izkušnje z zdravljenjem bolnikov z vnetno boleznijo črevesja v anamnezi so zelo omejene.
English: • liver damage
Slovenian: • poškodba jeter
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.
Slovenian: V primerjavi s kontrolnimi kraki kliničnih študij idelaliziba je bilo večje pogostosti okužb na splošno, vključno z okužbami 3. in 4. stopnje, opaziti v krakih z idelalizibom.
English: ANTI-HYPERTENSIVES
Slovenian: ANTIHIPERTENZIVI
English: Buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem
Slovenian: SEDATIVI/HIPNOTIKI midazolam (peroralni), triazolam buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem
English: Zydelig contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Slovenian: Zdravilo Zydelig vsebuje azobarvilo sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
English: Pink, oval-shaped, film-coated tablet of dimensions 10.0 mm by 6.8 mm, debossed on one side with “GSI” and “150” on the other side.
Slovenian: Rožnata, ovalna, filmsko obložena tableta z merami 10,0 mm x 6,8 mm, ki ima na eni strani vtisnjeno oznako "GSI" in na drugi strani "150".
English: Regular clinical and laboratory monitoring for CMV infection is recommended in patients with positive CMV serology at the start of treatment with idelalisib or with other evidence of a history of CMV infection.
Slovenian: Pri bolnikih s pozitivno serologijo za CMV na začetku zdravljenja z idelalizibom ali pri bolnikih z drugimi znaki zgodovine okužbe s CMV se priporoča izvajanje rednih kliničnih in laboratorijskih pregledov za okužbo s CMV.
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.
Slovenian: Končni razpolovni čas izločanja idelaliziba je bil 8,2 (razpon: 1,9; 37,2) uri in navidezni očistek idelaliziba je bil 14,9 (razpon: 5,1; 63,8) l/h po peroralnem dajanju idelaliziba 150 mg dvakrat na dan.
English: The median age was 68 years (range: 61 to 74) with 64.0% of subjects over 65 years; 71.3% were male, and 84.3% were white; 63.6% had a Rai stage of III or IV, and 58.2% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 39.5% had a 17p chromosomal deletion and/or TP53 mutation, and 78.5% had unmutated genes for IGHV.
Slovenian: Mediana starost je bila 68 let (razpon: od 61 do 74), pri čemer je bilo 64,0 % oseb starih več kot 65 let, 71,3 % je bilo moških, 84,3 % belcev, 63,6 % s stadijem Rai III ali IV in 58,2 % s stadijem Binet C. Večina oseb je imela neugodne citogenetske prognostične dejavnike: 39,5 % je imelo kromosomsko delecijo 17p in/ali mutacijo TP53 in 78,5 % je imelo nemutirane gene za IGHV.
English: CI: confidence interval; O: ofatumumab; N: number of subjects per group
Slovenian: IZ: interval zaupanja; O: ofatumumab; N: število oseb na skupino
English: Clinical efficacy in chronic lymphocytic leukaemia
Slovenian: Klinična učinkovitost pri kronični limfocitni levkemiji
English: If SJS or TEN is suspected, idelalisib should be immediately interrupted and the patient treated accordingly.
Slovenian: Pri sumu na SJS ali TEN je treba idelalizib nemudoma prekiniti in bolnika ustrezno zdraviti.
English: Clinical monitoring is recommended for telithromycin.
Slovenian: Za telitromicin se priporoča klinično spremljanje.
English: Orange, oval-shaped, film-coated tablet of dimensions 9.7 mm by 6.0 mm, debossed on one side with “GSI” and “100” on the other side.
Slovenian: Oranžna, ovalna, filmsko obložena tableta z merami 9,7 mm x 6,0 mm, ki ima na eni strani vtisnjeno oznako "GSI" in na drugi strani "100".
English: No mechanistic explanations for the development of resistance to treatment with idelalisib have been identified from clinical studies.
Slovenian: Klinične študije niso prinesle razlag glede mehanizma razvoja odpornosti na zdravljenje z idelalizibom.
English: PHOSPHODIESTERASE INHIBITORS
Slovenian: ZAVIRALCI FOSFODIESTERAZE
English: ↑ serum concentrations Anticonvulsant drug levels should be monitored.
Slovenian: ↑ koncentracij v serumu Spremljati je treba ravni antikonvulzivov.
English: Idelalisib should not be co-administered with amiodarone or quinidine.
Slovenian: Idelaliziba se ne sme dati sočasno z amiodaronom in kinidinom.
English: Cases of pneumonitis and organising pneumonia (some with fatal outcome) have been reported with idelalisib.
Slovenian: Pri uporabi idelaliziba so poročali o primerih pnevmonitisa in organizirajoče pljučnice (z nekaj smrtnimi izidi).
English: Study 312-0119 was a randomised, controlled, open-label study in which 173 subjects with previously treated CLL received idelalisib + ofatumumab.
Slovenian: Študija 312-0119 je bila randomizirana, kontrolirana, odprta študija, v kateri je 173 oseb s predhodno zdravljeno KLL prejemajo idelalizib + ofatumumab.
English: ANTICOAGULANTS
Slovenian: ANTIKOAGULANTI
English: Clinical recommendation upon co-administration with idelalisib
Slovenian: Klinično priporočilo pri sočasnem dajanju z idelalizibom
English: Zydelig is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Zydelig vplivalo na sposobnost vožnje ali upravljanja strojev.
English: • alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used for pain relief
Slovenian: • alfentanil, fentanil, metadon, buprenorfin/nalokson, zdravila, ki se uporabljajo za lajšanje bolečine
English: Study 312-0116 was a randomised, double-blind, placebo-controlled study in which 110 subjects with previously treated CLL received idelalisib + rituximab.
Slovenian: Študija 312-0116 je bila randomizirana, dvojno slepa, s placebom kontrolirana študija, v kateri je 110 oseb s predhodno zdravljeno KLL prejemalo idelalizib + rituksimab.
English: Ciclosporin, sirolimus, tacrolimus
Slovenian: IMUNOSUPRESIVI ciklosporin, sirolimus, takrolimus
English: • carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
Slovenian: • karbamazepin, S-mefenitoin, fenitoin, zdravila, ki se uporabljajo za preprečevanje epileptičnih napadov
English: The primary metabolite of idelalisib, GS-563117, is a strong CYP3A4 inhibitor.
Slovenian: Primarni presnovek idelaliziba, GS-563117, je močan zaviralec CYP3A4.
English: The primary metabolite of idelalisib, GS-563117, is a strong CYP3A inhibitor.
Slovenian: Primarni presnovek idelaliziba, GS-563117, je močan zaviralec CYP3A.
English: You will need regular blood tests before and during treatment with Zydelig.
Slovenian: Pred zdravljenjem z zdravilom Zydelig in med njim boste morali opravljati redne krvne preiskave.
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 rash.
Slovenian: Zdravljenje z zdravilom Zydelig je treba začasno ustaviti, če se pojavi izpuščaj 3. ali 4. stopnje.
English: Microcrystalline cellulose, hydroxypropyl cellulose (E463), croscarmellose sodium, sodium starch glycolate, magnesium stearate.
Slovenian: Jedro tablete: mikrokristalna celuloza, hidroksipropilceluloza (E463), premreženi natrijev karmelozat, natrijev karboksimetilškrob, magnezijev stearat.
English: ANTI-PSYCHOTICS/NEUROLEPTICS
Slovenian: ANTIPSIHOTIKI/NEVROLEPTIKI kvetiapin, pimozid
English: ↑ serum concentrations Idelalisib should not be co-administered with quetiapine or pimozide.
Slovenian: ↑ koncentracij v serumu Idelaliziba se ne sme dati sočasno s kvetiapinom ali pimozidom.
English: • amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
Slovenian: • amiodaron, bepridil, dizopiramid, lidokain, kinidin; zdravila, ki se uporabljajo za zdravljenje težav s srcem
English: • Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Zydelig, and for 1 month after your last treatment.
Slovenian: • Med zdravljenjem z zdravilom Zydelig in še 1 mesec po zadnjem zdravljenju uporabljajte zanesljivo kontracepcijsko metodo, da ne zanosite.
English: The film-coated tablets are orange, oval-shaped tablets, debossed on one side with “GSI” and “100” on the other side.
Slovenian: Filmsko obložene tablete so oranžne, ovalne tablete, ki imajo na eni strani vtisnjeno oznako "GSI" in na drugi strani "100".
English: The film-coated tablets are pink, oval-shaped tablets, debossed on one side with “GSI” and “150” on the other side.
Slovenian: Filmsko obložene tablete so rožnate, ovalne tablete, ki imajo na eni strani vtisnjeno oznako "GSI" in na drugi strani "150".
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.
Slovenian: Če se ta dogodek ne pojavi ponovno, se lahko odmerek po presoji lečečega zdravnika ponovno poveča na 150 mg dvakrat na dan.
English: Figure 2: Kaplan-Meier curve of PFS from study 312-0119 (intent-to-treat population)
Slovenian: Slika 2: Kaplan Meierjeva krivulja PFS iz študije 312-0119 (populacija z namenom zdravljenja)
English: A study of pharmacokinetics and safety of idelalisib was performed in healthy subjects and subjects with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Slovenian: Pri zdravih osebah in pri osebah z zmerno (razred B po Child-Pughu) in hudo jetrno okvaro (razred C po Child-Pughu) so izvedli študijo farmakokinetike in varnosti idelaliziba.
English: Each film-coated tablet contains 100 mg of idelalisib.
Slovenian: Ena filmsko obložena tableta vsebuje 100 mg idelaliziba.
English: Figure 1: Kaplan-Meier curve of PFS from study 312-0116 (intent-to-treat population)
Slovenian: Slika 1: Kaplan Meierjeva krivulja PFS iz študije 312-0116 (populacija z namenom zdravljenja)
English: Tell your doctor right away if you become ill (especially with a fever, cough or breathing difficulties) while you are taking Zydelig.
Slovenian: Če med jemanjem zdravila Zydelig zbolite, o tem nemudoma obvestite svojega zdravnika (zlasti če se pojavijo povišana telesna temperatura, kašelj ali težave z dihanjem).
English: Film-coated tablets 60 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložene tablete 60 filmsko obloženih tablet
English: ↑ serum concentrations ↑ serum concentrations
Slovenian: ↑ koncentracij v serumu ↑ koncentracij v serumu
English: Upon initiation of idelalisib, a temporary increase in lymphocyte counts (i.e., ≥ 50% increase from baseline and above absolute lymphocyte count of 5,000/mcL) has been observed.
Slovenian: ≥ 50 % zvišanje od začetne vrednosti in nad absolutno vrednostjo limfocitov v višini 5.000/mcL).
English: (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko največ 1 od 10 oseb)
English: Idelalisib was not carcinogenic at exposures up to 1.4/7.9-fold (male/female) in mice compared to the exposure in patients with haematologic malignancies administered the recommended dose of 150 mg twice daily.
Slovenian: Pri izpostavljenostih do 1,4/7,9-kratne izpostavljenosti (samci/samice) pri miših v primerjavi z izpostavljenostmi pri bolnikih s hematološkimi malignostmi, ki so prejemali priporočeni odmerek 150 mg dvakrat na dan, idelalizib ni bil kancerogen.
English: GASTROINTESTINAL MOTILITY AGENTS
Slovenian: ZDRAVILA, KI VPLIVAJO NA GASTROINTESTINALNO MOTILITETO cisaprid
English: Tell your doctor if you have an allergy to sunset yellow FCF (E110).
Slovenian: Zdravilo Zydelig vsebuje barvilo sončno rumeno FCF (E110) Povejte zdravniku, če ste alergični na barvilo sončno rumeno FCF (E110).
English: Idelalisib in combination with rituximab
Slovenian: Idelalizib v kombinaciji z rituksimabom
English: Table 4: Summary of PFS and response rates in pre-specified subgroups from study 312-0116 Idelalisib + R
Slovenian: Preglednica 4: Povzetek PFS in stopnje odziva v vnaprej specificiranih podskupinah iz študije 312-0116