FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Id-DOR medjan għall-individwi kollha kien ta' 12.5 xhur (12.5 xhur għal individwi b'SLL, u 11.8 xhur għal individwi b'FL, 20.4 xhur għal individwi b'LPL/WM u 18.4 xhur għal individwi b'MZL).
English: ↑ serum concentrations It is recommended that the international normalised ratio (INR) be monitored upon co-administration and following ceasing treatment with idelalisib.
Maltese: Hu rakkomandat li l-proporzjon normalizzat internazzjonali (INR) jiġi mmonitorjat meta jingħata flimkien u wara t-twaqqif tat-trattament b'idelalisib.
English: • bosentan, a medicine used to treat pulmonary arterial hypertension
Maltese: • bosentan, mediċina li tintuża għat-trattament ta' pressjoni għolja arterjali pulmonari
English: However, idelalisib did not inhibit the normal host response to Staphylococcus aureus and did not exacerbate the myelosuppressive effect of cyclophosphamide.
Maltese: Madankollu, idelalisib ma inibixxix ir-rispons tal-ospitu normali għal Staphylococcus aureus u ma ħarrax l-effett majelosuppressiv ta' cyclophosphamide.
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.
Maltese: Meta mqabbla ma' rituximab + plaċebo, it-trattament b'idelalisib + rituximab wassal għal titjib statistikament sinifikanti u li jagħmel sens mil-lat kliniku fil-benesseri fiżiku, il-benesseri soċjali, ilbenesseri funzjonali, kif ukoll fis-sottoskali speċifiċi għal-lewkimja tal-Evalwazzjoni Funzjonali talKura għall-Kanċer: strumenti tal-Lewkemija (FACT-LEU - Functional Assessment of Cancer
English: Skin and subcutaneous tissue disorders Rash***
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Raxx***
English: PFS median (months) (95% CI)
Maltese: PFS Medjan (xhur) (95% CI)
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.
Maltese: Mal-bidu ta' idelalisib, kienet osservata żieda temporanja fl-għadd tal-limfoċiti (jiġifieri, żieda ta' ≥ 50% mil-linja bażi u 'l fuq mill-għadd assolut tal-limfoċiti ta' 5,000/mcL).
English: ↑ serum concentrations Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
Maltese: Monitoraġġ b'attenzjoni tarreazzjonijiet avversi (eż., tnaqqis respiratorju, sedazzjoni) hu rakkomandat.
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.
Maltese: Ebda aġġustament tad-doża tal-bidu ta' idelalisib ma huwa meqjus neċessarju meta mogħti ma' inibituri ta' CYP3A/P-gp, imma monitoraġġ intensifikat ta' reazzjonijiet avversi hu rakkomandat.
English: CI: confidence interval; R: rituximab; N: number of subjects per group; NR: not reached
Maltese: CI: intervall ta' kunfidenza; R: rituximab; N: l-għadd ta' individwi f'kull grupp; NR: ma ntlaħaqx
English: Elderly No specific dose adjustment is required for elderly patients (aged ≥ 65 years) (see section 5.2).
Maltese: L-ebda aġġustament speċifiku fid-doża ma huwa meħtieġ għal pazjenti anzjani (b'età ≥ 65 sena) (ara sezzjoni 5.2).
English: A dose-related increase in pancreatic islet cell tumors was observed at low incidence in male rats at exposures up to 0.4-fold compared to the human exposure at the recommended dose; a similar finding was not observed in female rats at 0.62-fold exposure margin.
Maltese: Ġiet osservata żieda marbuta mad-doża f'tumuri f'ġemgħa ta' ċelluli mxerrdin mal-frixa b'inċidenza baxxa f'firien irġiel f'esponimenti sa 0.4 darbiet meta mqabbla mal-esponiment tal-bniedem bid-doża rakkomandata; sejba simili ma ġietx osservata f'firien nisa f'marġni ta' esponiment ta' 0.62 darba.
English: Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS^ Median (months) (95% CI)
Maltese: Proporzjon ta' periklu (95% CI) Valur p ORR* n (%) (95% CI) Proporzjon ta' odds (95% CI) Valur p LNR** n/N (%) (95% CI) Proporzjon ta' odds (95% CI) Valur p OS^ Medjan (xhur) (95% CI)
English: Contents of the pack and other information What Zydelig contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Zydelig
English: The first infusion of ofatumumab was administered at a dose of 300 mg and was continued at a dose of either 1,000 mg in the idelalisib + ofatumumab group or a dose of 2,000 mg in the ofatumumab only group, weekly for 7 doses, and then every 4 weeks for 4 doses.
Maltese: L-ewwel infużjoni ta' ofatumumab ingħatat f'doża ta' 300 mg u tkompliet f'doża ta' jew 1,000 mg fil-grupp ta' idelalisib + ofatumumab, jew f'doża ta' 2,000 mg fil-grupp ta' ofatumumab biss, kull ġimgħa għal 7 dożi, u mbagħad kull 4 ġimgħat għal 4 dożi.
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.
Maltese: L-individwi kienu randomised fi proporzjon ta' 2:1 biex jirċievu idelalisib 150 mg darbtejn kuljum u 12-il infużjoni ta' ofatumumab fuq perjodu ta' 24 ġimgħa, jew 12-il infużjoni ta' ofatumumab biss fuq perjodu ta' 24 ġimgħa.
English: Paediatric population The pharmacokinetics of idelalisib in paediatric subjects has not been established (see section 4.2).
Maltese: Il-farmakokinetika ta' idelalisib f'individwi pedjatriċi ma ġietx stabbilita (ara sezzjoni 4.2).
English: Population pharmacokinetic analyses indicated that gender and race had no clinically relevant effect on the exposures to idelalisib or GS-563117.
Maltese: Analiżi farmakokinetika tal-popolazzjoni indikat li s-sess u r-razza ma kellhom l-ebda effett klinikament rilevanti fuq l-espożizzjonijiet għal idelalisib jew GS-563117.
English: PFS Median (months) (95% CI) Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS Median (months) (95% CI)
Maltese: PFS Medjan (xhur) (95% CI) Proporzjon ta' periklu (95% CI) Valur p ORR* n (%) (95% CI) Proporzjon ta' odds (95% CI) Valur p LNR** n/N (%) (95% CI) Proporzjon ta' odds (95% CI) Valur p OS Medjan (xhur) (95% CI)
English: Adverse reactions are listed by system organ class and frequency.
Maltese: Irreazzjonijiet avversi huma elenkati skont il-klassi tas-sistemi u tal-organi u l-frekwenza.
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.
Maltese: Analiżi farmakokinetika tal-popolazzjoni indikat li l-età ma kellha l-ebda effett klinikament rilevanti fuq l-espożizzjonijiet għal idelalisib jew GS-563117, inklużi individwi anzjani (età minn 65 sena 'l fuq), meta mqabbla ma' individwi iżgħar.
English: EU/1/14/938/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/938/002
English: Unmutated IGHV
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Idelalisib is not considered to have broad immunosuppressive activity.
Maltese: Idelalisib mhuwiex meqjus li għandu attività immunosuppressiva wiesgħa.
English: • atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol
Maltese: • atorvastatin, lovastatin, simvastatin, mediċini li jintużaw biex ibaxxu l-kolesterol
English: Clinical efficacy in chronic lymphocytic leukaemia
Maltese: Effikaċja klinika f'lewkimja limfoċitika kronika
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.
Maltese: PRs (78.1%); inkluż 3 CRs u 6 PRs fl-individwi bi tħassir ta' 17p u/jew mutazzjoni ta' TP53 u 2 CRs u 34 PRs f'individwi b'IGHV mingħajr mutazzjoni.
English: Tablet core
Maltese: TIKKETTA TAL-KARTUNA
English: The primary and only circulating metabolite, GS-563117, is inactive against PI3Kδ.
Maltese: Il-metabolit primarju u l-uniku wieħed li jiċċirkola, GS-563117, huwa inattiv kontra PI3Kδ.
English: ANALGESICS
Maltese: ANALĠESIĊI
English: Pneumonitis and organising pneumonia
Maltese: Pulmonite u pulmonite organizzattiva
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.
Maltese: L-Istudju 312-0116 kien studju randomised, double-blind u kkontrollat bi plaċebo ta' Fażi 3 fuq 220 individwu b'CLL ittrattati fil-passat li kienu jeħtieġu trattament iżda ma kinux meqjusa addattati għal kimoterapija ċitotossika.
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.
Maltese: L-età medjana kienet ta' 68 sena (medda: 61 sa 74) b'64.0% tal-individwi li kellhom aktar minn 65 sena; 71.3% kienu rġiel, u 84.3% kienu bojod; 63.6% kellhom stadju Rai ta' III jew IV, u 58.2% kellhom Binet Stadju Ċ.
English: CI: confidence interval; O: ofatumumab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Maltese: CI: intervall ta' kunfidenza; O: ofatumumab; n: l-għadd ta' individwi li rrispondew; N: l-għadd ta' individwi f'kull grupp; NR: ma ntlaħaqx.
English: Gilead Sciences GesmbH Tel: + 43 1 260 830
Maltese: Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
English: Idelalisib exposure may be reduced when co-administered with CYP3A inducers such as rifampicin, phenytoin, St. John's wort (Hypericum perforatum), or carbamazepine.
Maltese: L-esponiment għal Idelalisib jista' jitnaqqas meta mogħti fl-istess ħin ma' indutturi ta' CYP3A bħal rifampicin, phenytoin, St.
English: Its primary metabolite is GS-563117, which is not pharmacologically active.
Maltese: GS-563117, li mhuwiex farmakoloġikament attiv.
English: CI: confidence interval; R: rituximab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Maltese: CI: intervall ta' kunfidenza; R: rituximab; n: l-għadd ta' individwi li rrispondew, N: l-għadd ta' individwi f'kull grupp; NR: ma ntlaħaqx.
English: Table 4: Summary of PFS and response rates in pre-specified subgroups from study 312-0116 Idelalisib + R
Maltese: Tabella 4: Sommarju tal-PFS u r-rati ta' rispons f'sottogruppi speċifikati minn qabel mill istudju 312-0116
English: For pulmonary arterial hypertension:
Maltese: Għal pressjoni għolja arterjali pulmonari:
English: The median time from diagnosis of CLL to randomisation was 8.5 years.
Maltese: Iż-żmien medjan mid dijanjosi ta' CLL sa randomisation kien ta' 8.5 snin.
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.
Maltese: Wara l-għoti ta' doża unika ta' idelalisib mill-ħalq, il-konċentrazzjonijiet massimi fil-plasma kienu osservati minn sagħtejn sa 4 sigħat wara d-doża taħt kondizzjonijiet mitmugħa u wara 0.5 sa 1.5 siegħa taħt kondizzjonijiet ta' sawm.
English: Idelalisib did not induce mutations in the microbial mutagenesis (Ames) assay, was not clastogenic in the in vitro chromosome aberration assay using human peripheral blood lymphocytes, and was not genotoxic in the in vivo rat micronucleus study.
Maltese: Idelalisib ma kkawżax mutazzjonijiet fl-analiżi tal-mutaġenesi fil-mikrobi (Ames), ma kienx klastoġeniku fl-analiżi in vitro tal-aberrazzjoni tal-kromożomi bl-użu ta' limfoċiti tad-demm periferali tal-bniedem, u ma kellux effett tossiku fuq il-ġeni fl-istudju in vivo tal-mikronukleji tal-firien.
English: Treatment-emergent Grade 3 or 4 neutropenia, including febrile neutropenia, have occurred in patients treated with idelalisib.
Maltese: Newtropenija li tiżviluppa minħabba t-trattament ta' grad 3 jew 4 (treatment-emergent Grade 3 or 4 neutropenia), li tinkludi newtropenija bid-deni, seħħet f'pazjenti ttrattati b'idelalisib.
English: Table 6: Summary of PFS and response rates in pre-specified subgroups from study 312-0119 Idelalisib + O Ofatumumab
Maltese: Tabella 6: Sommarju tal-PFS u rati ta' rispons f'sottogruppi speċifikati minn qabel mill istudju 312-0119
English: • alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used for pain relief
Maltese: • alfentanil, fentanyl, methadone, buprenorphine/naloxone, mediċini li jintużaw għas-serħan mill-uġigħ
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.
Maltese: Ir-reazzjonijiet avversi tal-mediċina rrappurtati b'idelalisib waħdu jew f'kombinazzjoni ma' antikorpi monoklonali anti-CD20 (rituximab jew ofatumumab) huma pprovduti fil-qosor f'Tabella 2.
English: Table 5: Efficacy results from study 312-0119 Idelalisib + O N = 174
Maltese: Riżultati tal-effikaċja mill-istudju 312-0119 Idelalisib + O
English: ENDOTHELIN RECEPTOR ANTAGONISTS
Maltese: IL-PRODOTT MEDIĊINALI
English: Among the 122 subjects with measurable lymph nodes at both baseline and post-baseline, 71 subjects (58.2%) achieved a ≥ 50% decrease from baseline in the sum of the products of the diameters (SPD) of index lesions.
Maltese: Fost il-122 individwu li kellhom glandoli limfatiċi li setgħu jitkejlu kemm fil-linja bażi kif ukoll wara l-linja bażi, 71 individwu (58.2%) kisbu tnaqqis ta' ≥ 50% mil-linja bażi fit-total talmultiplikazzjoni tad-dijametri (SPD - sum of the products of the diameters) ta' leżjonijiet indiċi.
English: PC:
Maltese: Тел.:
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).
Maltese: It-tul ta' profilassi wara t-trattament għandu jkun ibbażat fuq ġudizzju kliniku u jista' jikkunsidra fatturi ta' riskju tal-pazjent bħal trattament b'kortikosterojdi fl-istess ħin u newtropenija fit-tul (ara sezzjoni 4.8).
English: Zydelig 150 mg film-coated tablets
Maltese: Zydelig 150 mg pilloli miksija b'rita
English: Gastrointestinal disorders Diarrhoea/colitis
Maltese: Disturbi gastro-intestinali
English: The median age was 71 years (range: 47 to 92) with 78.2% of subjects over 65 years; 65.5% were male, and 90.0% were white; 64.1% had a Rai stage of III or IV, and 55.9% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 43.2% had a 17p chromosomal deletion and/or tumour protein 53 (TP53) mutation, and 83.6% had unmutated genes for the immunoglobulin heavy chain variable region (IGHV).
Maltese: Il-biċċa l-kbira tal-individwi kellhom fatturi pronostiċi ċitoġeniċi avversi: 43.2% kellhom tħassir kromosomali ta' 17p u/jew mutazzjoni fil-proteina 53 tat-tumur (TP53 - tumour protein 53), u 83.6% kellhom ġeni mingħajr mutazzjoni għar-reġjun varjabbli tal-katina tqila tal immunoglubulina (IGHV - immunoglobulin heavy chain variable region).
English: The safety and efficacy of Zydelig in children under the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Zydelig fit-tfal taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Ofatumumab N = 87
Maltese: N = 87
English: ↑ serum concentrations Clinical monitoring is recommended.
Maltese: Monitoraġġ kliniku hu rakkomandat.
English: Alternative medicinal products, such as olanzapine, may be considered.
Maltese: Prodotti mediċinali alternattivi, bħal olanzapine, jistgħu jiġu kkunsidrati.
English: Idelalisib has not been studied in patients with chronic active hepatitis including viral hepatitis.
Maltese: Idelalisib ma ġiex studjat f'pazjenti b'epatite kronika attiva li tinkludi epatite virali.
English: • pimozide, a medicine used to treat abnormal thoughts or feelings
Maltese: • pimozide, mediċina li tintuża għal trattament ta' ħsibijiet jew sensazzjonijiet mhux normali
English: Bosentan
Maltese: Pożoloġija
English: Alternatively, switching to pravastatin, rosuvastatin, or pitavastatin may be considered.
Maltese: Alternattivament, li taqleb għal pravastatin, rosuvastatin, jew pitavastatin jista' jiġi kkunsidrat.
English: DOR (months) median (95% CI) PFS (months) median (95% CI) OS (months) median (95% CI)
Maltese: DOR (xhur) medjan (CI ta' 95%) PFS (xhur) medjan (CI ta' 95%) OS (xhur) medjan (CI ta' 95%)
English: Animal studies indicate the potential for harmful effects of idelalisib on fertility and foetal development (see section 5.3).
Maltese: Studji fuq lannimali jindikaw il-potenzjal għal effetti ta' ħsara ta' idelalisib fuq il-fertilità u fuq l-iżvilupp tal-fetu (ara sezzjoni 5.3).
English: Monitor ANC at least weekly until ANC ≥ 500/mm3, then may resume Zydelig dosing at 100 mg twice daily.
Maltese: Immonitorja l-ANC mill-inqas darba f'ġimgħa sa meta jkun hemm ANC ≥ 500/mm3, imbagħad tkun tista' terġa' tibda Zydelig f'doża ta' 100 mg darbtejn kuljum.
English: This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
Maltese: Din il-limfoċitożi osservata hija effett farmakodinamiku u m'għandhiex titqies bħala marda progressiva fin-nuqqas ta' sejbiet kliniċi oħra.
English: If diarrhoea/colitis does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Maltese: Jekk id-dijarea/kolite ma terġax isseħħ, id-doża tista' terġa' tiżdied għal 150 mg darbtejn kuljum fid-diskrezzjoni tat-tabib (ara sezzjoni 4.8).
English: The median time since diagnosis was 7.7 years.
Maltese: Iż-żmien medjan mid-dijanjosi kien ta' 7.7 snin.
English: If either moderate or severe symptomatic pneumonitis or organising pneumonia is diagnosed, appropriate treatment should be initiated and idelalisib must be permanently discontinued.
Maltese: Jekk tiġi dijanjostikata pulmonite sintomatika moderata jew severa jew inkella pulmonite organizzattiva, għandu jinbeda trattament xieraq u idelalisib irid jitwaqqaf b'mod permanenti.
English: Package leaflet: Information for the patient Zydelig 150 mg film-coated tablets idelalisib
Maltese: Informazzjoni għall-pazjent Zydelig 150 mg pilloli miksija b'rita idelalisib
English: ↑ serum concentrations Clinical monitoring of therapeutic effect and adverse reactions is recommended.
Maltese: Monitoraġġ kliniku tal-effett terapewtiku u r-reazzjonijiet avversi hu rakkomandat.
English: However, your doctor may reduce this dose to 100 mg twice a day if you experience particular side effects.
Maltese: Madankollu, it-tabib tiegħek jista' jnaqqas din id-doża għal 100 mg darbtejn kuljum jekk ikollok effetti sekondarji partikolari.
English: ↑ serum concentrations Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.
Maltese: Titrazzjoni b'kawtela tad-doża talantidepressant u monitoraġġ għarrispons tal-antidepressant huma rakkomandati.
English: • fever
Maltese: • infezzjonijiet
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Maltese: F'każ ta' doża eċċessiva, il-pazjent għandu jiġi mmonitorjat għal evidenza ta' tossiċità (ara sezzjoni 4.8).
English: *** Includes the preferred terms dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule, skin plaque, and exfoliative rash.
Maltese: Komuni * Komposti minn infezzjonijiet opportunistiċi kif ukoll infezzjonijiet ikkawżati minn batterji u viruses bħal pulmonite, bronkite, u sepsi. ** Il-limfoċitożi kkawżata minn idelalisib m'għandhiex titqies bħala marda progressiva fin-nuqqas ta' sejbiet kliniċi oħra (ara sezzjoni 5.1). *** Jinkludi t-termini preferuti dermatite bil-qxur ġeneralizzata, reazzjoni avversa fil-ġilda kkawżata millmediċina, raxx, raxx eritematiku, raxx ġeneralizzat, raxx makulari, raxx makulo-papulari, raxx papulari, raxx pruritiku, raxx bil-ponot, raxx bl-infafet, nuffata, qoxra fuq ġilda infjammata, u raxx bil-qxur.
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.
Maltese: Studju kliniku dwar l-interazzjoni bejn il-mediċina u mediċini oħra sab li l-għoti ta' doża waħda ta' 150 mg idelalisib flimkien ma' rifampicin (induttur qawwi ta' CYP3A) wassal għal tnaqqis ta' ~75% fl-AUCinf ta' idelalisib.
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.
Maltese: In vitro, idelalisib kemm inibixxa kif ukoll induċa CYP2C8, imma mhux magħruf jekk dan jittraduċix għal effett in vivo fuq substrati ta' CYP2C8.
English: Each film-coated tablet contains 150 mg of idelalisib.
Maltese: Id-doża rakkomandata hija ta' 150 mg idelalisib darbtejn kuljum.
English: Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of CYP2C8 (paclitaxel).
Maltese: Il-kawtela hi rakkomandata jekk Zydelig jintuża flimkien ma' mediċini b'indiċi terapewtiku dejjaq li huma substrati ta' CYP2C8 (paclitaxel).
English: Zydelig 100 mg film-coated tablets
Maltese: Zydelig 100 mg pilloli miksija b'rita
English: Zydelig is a cancer medicine that contains the active substance idelalisib.
Maltese: Zydelig hu mediċina tal-kanċer li fih is-sustanza attiva idelalisib.
English: Package leaflet: Information for the patient Zydelig 100 mg film-coated tablets idelalisib
Maltese: Informazzjoni għall-pazjent Zydelig 100 mg pilloli miksija b'rita idelalisib
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).
Maltese: Għaldaqstant, idelalisib għandu l-potenzjal li jinteraġixxi ma' prodotti mediċinali li jiġu metabolizzati minn CYP3A, li jista' jwassal għal żieda fil-konċentrazzjonijiet tas-serum tal-prodott l-ieħor (ara sezzjoni 4.5).
English: Ergotamine, dihydroergotamine ↑ serum concentrations Idelalisib should not be co-administered with ergotamine or dihydroergotamine.
Maltese: Ergotamine, dihydroergotamine ↑ konċentrazzjonijiet fis serum
English: Idelalisib should not be co-administered with amiodarone or quinidine.
Maltese: Kortikosterojdi li jinġibdu mannifs/nażali:
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.
Maltese: Id-deġenerazzjoni tat-tubuli seminiferużi fit-testikoli ġiet osservata fi studji b'dożi ripetuti ta' ġimagħtejn sa 13-il ġimgħa fi klieb u firien, iżda mhux fi studji ta' 26 ġimgħa u li damu iktar.
English: All subjects were refractory to rituximab and 124 of 125 subjects were refractory to at least one alkylating agent.
Maltese: L-individwi kollha kienu reżistenti għal rituximab u 124 mill-125 individwu kienu reżistenti għal mill-inqas sustanza alkilatika waħda.
English: Zydelig is for oral use.
Maltese: Zydelig huwa għal użu orali.
English: Blood counts should be monitored in all patients at least every 2 weeks for the first 6 months of treatment with idelalisib, and at least weekly in patients while ANC is less than 1,000 per mm3 (see section 4.2).
Maltese: trattament b'idelalisib, u mill-inqas darba f'ġimgħa fil-pazjenti waqt li l-ANC ikun inqas minn 1,000 kull mm3 (ara sezzjoni 4.2).