FrancophonIA/ELRC3.0 huggingface dataset:
English: The analysis of PFS was based on evaluation by an IRC.
Maltese: L-analiżi ta' PFS ġiet ibbażata fuq evalwazzjoni minn IRC.
English: There have also been reports of hepatocellular injury including hepatic failure.
Maltese: Kien hemm ukoll rapporti ta' ħsara epatoċellulari inkluż falliment epatiku.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX47
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, sustanzi antineoplastiċi oħrajn, Kodiċi ATC:
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.
Maltese: Data in vitro indikat li idelalisib mhuwiex inibitur tal-enzimi metabolizzanti CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A, jew UGT1A1, jew tat-trasportaturi
English: Zydelig contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Maltese: Zydelig fih is-sustanza koloranti azo sunset yellow FCF (E110), li tista' tikkawża reazzjonijiet allerġiċi.
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.
Maltese: Riskju għal inibizzjoni ta' P-gp fil-passaġġ gastrointestinali, li jista' jirriżulta f'esponiment miżjud ta' substrati sensittivi għal P-gp intestinali bħal dabigatran etexilate, ma jistax jiġi eskluż.
English: A clinical drug interaction study found that co-administration of a single dose of 400 mg idelalisib with 400 mg once daily ketoconazole (a strong CYP3A, P-gp and BCRP inhibitor) resulted in a 26% increase in Cmax and a 79% increase in AUCinf of idelalisib.
Maltese: Studju kliniku dwar l-interazzjoni bejn il-mediċina u mediċini oħra sab li l-għoti ta' doża waħda ta' 400 mg idelalisib flimkien ma' 400 mg darba kuljum ketoconazole (inibitur qawwi ta' CYP3A, P-gp u BCRP) wassal għal żieda ta' 26% fis-Cmax u żieda ta' 79% fl-AUCinf ta' idelalisib.
English: Following a single 150 mg oral dose of [14C]-labelled idelalisib, approximately 78% and 15% was excreted in faeces and urine, respectively.
Maltese: Wara doża unika ta' 150 mg ta' idelalisib ittikkettat b'[14C] millħalq, madwar 78% u 15% kien eliminat fl-ippurgar u fl-awrina, rispettivament.
English: Electrocardiographic
Maltese: Elettrokardjografiċi
English: The Phase 1 and 2 studies assessed the safety of idelalisib in a total of 536 subjects with haematologic malignancies, including 400 subjects who received idelalisib (any dose) as a single agent and 136 subjects who received idelalisib in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab).
Maltese: L-istudji ta' Fażi 1 u 2 evalwaw is-sigurtà ta' idelalisib f'total ta' 536 individwu b'tumuri malinni ematoloġiċi, fosthom 400 individwu li rċevew idelalisib (kwalunkwe doża) bħala sustanza unika u 136 individwu li rċevew idelalisib f'kombinazzjoni ma' antikorp monoklonali anti-CD20 (rituximab jew ofatumumab).
English: Study 312-0119 was a randomised, controlled, open-label study in which 173 subjects with previously treated CLL received idelalisib + ofatumumab.
Maltese: Studju 312-0119 kien studju randomised, ikkontrollat, open-label, li fih 173 individwu b'CLL ittrattati fil-passat, irċevew idelalisib + ofatumumab.
English: Follicular lymphoma
Maltese: Limfoma follikulari
English: Rash was generally mild to moderate and resulted in discontinuation of treatment in 2.1% of subjects.
Maltese: Ir-raxx kien ġeneralment ħafif għal moderat u wassal għal twaqqif tat-trattament fi 2.1% tal-individwi.
English: Study 312-0116 was a randomised, double-blind, placebo-controlled study in which 110 subjects with previously treated CLL received idelalisib + rituximab.
Maltese: Studju 312-0116 kien studju randomised, double-blind u kkontrollat bi plaċebo li fih 110 individwu b'CLL ittrattati fil-passat irċevew idelalisib + rituximab.
English: Stevens-Johnson syndrome and toxic epidermal necrolysis Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with fatal outcomes have been reported when idelalisib was administered concomitantly with other medicinal products associated with these syndromes.
Maltese: Sindrome ta' Stevens-Johnson u nekrolisi epidermali tossika Każijiet tas-sindrome ta' Stevens-Johnson (SJS) u nekrolisi epidermali tossika (TEN) b'riżultati fatali, ġew irrappurtati meta idelalisib ingħata fl-istess ħin ma' prodotti mediċinali oħrajn assoċjati ma' dawn is-sindromi.
English: Lovastatin, simvastatin
Maltese: INIBITURI TA' HMG CO-A REDUCTASE Lovastatin, simvastatin
English: Neutropenia Treatment with Zydelig should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm3.
Maltese: It-trattament b'Zydelig għandu jitwaqqaf f'pazjenti waqt li l-għadd assolut tan-newtrofili (absolute neutrophil count, ANC) jkun taħt 500 kull mm3.
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.
Maltese: Mit53 individwu li ma rrispondewx, 41 (32.8%) kellhom marda stabbli, 10 (8.0%) kellhom marda progressiva, u 2 (1.6%) ma setgħux jiġu evalwati.
English: Nearly all PJP infections, including fatal cases, occurred in the absence of PJP prophylaxis.
Maltese: Kważi l-infezzjonijiet kollha ta' PJP, inklużi każijiet fatali, seħħew fl-assenza ta' profilassi ta' PJP.
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.
Maltese: Sar studju tal-farmakokinetika u s-sigurtà ta' idelalisib fuq individwi f'saħħithom u fuq individwi b'indeboliment epatiku moderat (Child-Pugh Klassi B) jew sever (Child-Pugh Klassi Ċ).
English: ERGOT ALKALOIDS
Maltese: ALKALOJDI TAL-ERGOT
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.
Maltese: Il-valutazzjoni ta' reazzjonijiet avversi hija bbażata fuq żewġ studji (studju 312-0116 u studju 312-0119) ta' Fażi 3 u sitt studji ta' Fażi 1 u 2.
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.
Maltese: Il-half-life tal-eliminazzjoni terminali ta' idelalisib kienet ta' 8.2 (medda: 1.9; 37.2) sigħat u leliminazzjoni apparenti ta' idelalisib kienet ta' 14.9 (medda: 5.1; 63.8) L/h wara l-għoti ta' idelalisib 150 mg darbtejn kuljum mill-ħalq.
English: A clinical drug interaction study found that co-administration of idelalisib with midazolam (a sensitive CYP3A substrate) resulted in a ~140% increase in Cmax and a ~440% increase in AUCinf of midazolam due to the CYP3A inhibition by GS-563117.
Maltese: Studju kliniku dwar linterazzjoni bejn il-mediċina u mediċini oħra sab li l-għoti ta' idelalisib flimkien ma' midazolam (substrat sensittiv ta' CYP3A) wassal għal żieda ta' ~140% fis-Cmax u żieda ta' ~440% fl-AUCinf ta' midazolam minħabba l-inibizzjoni ta' CYP3A permezz ta' GS-563117.
English: Zydelig may be used for the treatment of two different cancers in adults:
Maltese: Zydelig jista' jintuża għat-trattament ta' żewġ kanċers differenti fl-adulti:
English: Cases of pneumonitis and organising pneumonia (some with fatal outcome) have been reported with idelalisib.
Maltese: Ġew irrapportati każijiet ta' pulmonite u ta' pulmonite organizzattiva (uħud b'eżitu fatali) b'idelalisib.
English: • Zydelig may make the contraceptive “pill” and implanted hormonal contraceptives work less well.
Maltese: • Zydelig jista' jagħmel il-“pillola” kontraċettiva u kontraċettivi ormonali impjantati jaħdmu inqas tajjeb.
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.
Maltese: Idelalisib mhux mibdul ammonta għal 23% tar-radjuattività totali rkuprata fl-awrina fuq 48 siegħa u 12% tar-radjuattività totali rkuprata fl-ippurgar fuq 144 siegħa.
English: Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
Maltese: Idelalisib jinduċi apoptożi u jinibixxi l-proliferazzjoni f'linji ta' ċelluli derivati minn ċelluli B malinni u f'ċelluli primarji tat-tumur.
English: Idelalisib in combination with rituximab
Maltese: Idelalisib f'kombinazzjoni ma' rituximab
English: The median number of prior therapies was 3.0.
Maltese: L-għadd medjan ta' terapiji preċedenti kien ta' 3.0.
English: Of these, 5.7% who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 1.5% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab) had rash of Grade 3, and no subjects had an adverse reaction of Grade 4.
Maltese: Minn dawn, 5.7% li rċivew idelalisib + antikorp monoklonali anti-CD20 (rituximab jew ofatumumab) u 1.5% li rċivew antikorp monoklonali anti-CD20 biss (rituximab jew ofatumumab) kellhom raxx ta' Grad 3, u ebda individwu ma kellu reazzjoni avversa ta' Grad 4.
English: Hazard ratio (95% CI) ORR (95% CI)
Maltese: Proporzjon ta' periklu (95% CI) ORR (95% CI)
English: Table 3: Efficacy results from study 312-0116 Idelalisib + R N = 110
Maltese: Tabella 3: Riżultati tal-effikaċja mill-istudju 312-0116 Idelalisib + R
English: Table 2: Adverse drug reactions reported in clinical studies in subjects with haematologic malignancies receiving idelalisib
Maltese: Tabella 2: Reazzjonijiet avversi tal-mediċina rrappurtati fi studji kliniċi f'individwi b'tumuri malinni ematoloġiċi li kienu qed jirċievu idelalisib
English: CI: confidence interval; O: ofatumumab; N: number of subjects per group
Maltese: CI: intervall ta' kunfidenza; O: ofatumumab; N: għadd ta' individwi f'kull grupp
English: Most frequently observed were infections in the respiratory system and septic events.
Maltese: Dawk osservati bl-aktar mod frekwenti kienu infezzjonijiet fis-sistema respiratorja u avvenimenti settiċi.
English: Study 101-08/99 enrolled 64 subjects with previously untreated CLL, including 5 subjects with small lymphocytic lymphoma (SLL).
Maltese: Fl-istudju 101-08/99 ħadu sehem 64 individwu b'CLL li ma kinitx ittrattata qabel, fosthom 5 individwi b'limfoma limfoċitika żgħira (SLL - small lymphocytic lymphoma).
English: Table 1: Interactions between idelalisib and other medicinal products that are CYP3A substrates
Maltese: Tabella 1: Interazzjonijiet bejn idelalisib u prodotti mediċinali oħrajn li huma substrati ta'
English: Tablet core:
Maltese: Tabella 7:
English: Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 0.1 mg ta' sunset yellow FCF (E110) (ara sezzjoni 4.4).
English: Zydelig contains sunset yellow FCF which may cause allergic reactions.
Maltese: Zydelig fih sunset yellow FCF li jista' jikkawża reazzjonijiet allerġiċi.
English: Clinical efficacy in follicular lymphoma
Maltese: Effikaċja klinika f'limfoma follikulari
English: Subjects were randomised 1:1 to receive 8 cycles of rituximab (first cycle at 375 mg/m2 body surface area [BSA], subsequent cycles at 500 mg/m2 BSA) in combination with either an oral placebo twice daily or with idelalisib 150 mg taken twice daily until disease progression or unacceptable toxicity.
Maltese: L-individwi kienu randomised 1:1 biex jirċievu 8 ċikli ta' rituximab (lewwel ċiklu f'375 mg/m2 tal-erja tas-superfiċje tal-ġisem [BSA - body surface area], ċikli sussegwenti f'500 mg/m2 BSA) f'kombinazzjoni ma' plaċebo orali darbtejn kuljum jew ma' idelalisib 150 mg meħud darbtejn kuljum sakemm il-marda pprogressat jew kien hemm tossiċità inaċċettabbli.
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.
Maltese: mm b'6.8 mm, imnaqqxa b'“GSI” fuq naħa waħda u “150” fuq in-naħa l-oħra.
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.
Maltese: Studju 312-0119 kien studju randomised ta' Fażi 3, open-label, multiċentriku, b'grupp parallel, li sar fuq 261 individwu b'CLL ittrattati fil-passat, li kellhom limfadenopatija li setgħet titkejjel, kienu jeħtieġu t-trattament, u kellhom progressjoni ta' CLL < 24 xahar minn meta lestew l-aħħar terapija preċedenti.
English: A study of pharmacokinetics and safety of idelalisib was performed in healthy subjects and subjects with severe renal impairment (estimated CrCl 15 to 29 mL/min).
Maltese: Sar studju tal-farmakokinetika u s-sigurtà ta' idelalisib fuq individwi f'saħħithom u fuq individwi b'indeboliment renali sever (CrCl stmata 15 sa 29 mL/min).
English: ^ Overall survival (OS) analysis includes data from subjects who received placebo + R on study 312-0116 and subsequently received idelalisib in an extension study, based on intent-to-treat analysis.
Maltese: ^ Analiżi tas-sopravivenza globali (OS - overall survival) tinkludi data minn individwi li rċivew plaċebo + R flistudju 312-0116 u sussegwentement irċievew idelalisib fi studju ta' estensjoni, ibbażat fuq analiżi intent-to-treat.
English: Rash typically resolved with treatment (e.g., topical and/or oral steroids, diphenhydramine) and dose interruption for severe cases (see section 5.3, phototoxicity).
Maltese: Normalment, ir-raxx għadda bit-trattament (eż. sterojdi topiċi u/jew orali, diphenhydramine) u hekk kif id-doża twaqqfet għal każijiet severi (ara sezzjoni 5.3, fototossiċità).
English: Contains sunset yellow FCF (E110), see leaflet for further information.
Maltese: TA' EĊĊIPJENTI Fih sunset yellow FCF (E110), ara l-fuljett għal aktar informazzjoni.
English: Other medicines and Zydelig
Maltese: Mediċini oħra u Zydelig
English: In many instances the pathogen was not identified; however, both conventional and opportunistic pathogens, including PJP and CMV, were among those identified.
Maltese: F'ħafna każijiet, il-patoġenu ma kienx identifikat; madankollu, kemm patoġeni konvenzjonali kif ukoll opportunistiċi, inkluż PJP u CMV, kienu fost dawk identifikati.
English: The primary metabolite of idelalisib, GS-563117, is a strong CYP3A4 inhibitor.
Maltese: Il-metabolit primarju ta' idelalisib, GS-563117, hu inibitur qawwi ta' CYP3A4.
English: Hazard ratio (95% CI) P-value
Maltese: Proporzjon ta' odds (95% CI) Valur p
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
Maltese: Ilkombinazzjoni tista' tirriżulta f'riskju miżjud ta' avvenimenti avversi kardjovaskulari assoċjati ma' salmeterol, li jinkludu titwil tal-QT, palpitazzjonijiet, u takikardija tassinus.
English: Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of these enzymes (warfarin, phenytoin, S-mephenytoin).
Maltese: Il-kawtela hi rakkomandata jekk Zydelig jintuża flimkien ma' mediċini b'indiċi terapewtiku dejjaq li huma substrati ta' dawn l-enzimi (warfarin, phenytoin, S-mephenytoin).
English: At a dose 2.7 times the maximum recommended dose, idelalisib did not prolong the QT/QTc interval (i.e.,< 10 ms).
Maltese: F'doża li hija 2.7 drabi d-doża massima rakkomandata, idelalisib ma tawwalx l-intervall QT/QTc (jiġifieri,
English: Clinical monitoring is recommended for increased signs/symptoms of corticosteroid effects.
Maltese: Monitoraġġ kliniku hu rakkomandat għal sinjali/sintomi miżjuda ta' effetti tal-kortikosterojdi.
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Sunset yellow FCF (E110)
Maltese: Polyvinyl alcohol (E1203), macrogol 3550 (E1521), titanium dioxide (E171), talc (E553B),
English: The safety and efficacy of idelalisib were assessed in a single-arm, multicentre clinical study (study 101-09) conducted in 125 subjects with indolent B-cell non-Hodgkin lymphoma (iNHL, including: FL, n = 72; SLL, n = 28; lymphoplasmacytic lymphoma/Waldenström macroglobulinaemia [LPL/WM], n = 10; and marginal zone lymphoma [MZL], n = 15).
Maltese: Is-sigurtà u l-effikaċja ta' idelalisib kienu evalwati fi studju kliniku b'fergħa unika u multiċentriku (studju 101-09) li sar fuq 125 individwu b'limfoma indolenti mhux ta' Hodgkin taċ-ċellula B (iNHLindolent non-Hodgkin lymphoma, inkluż:
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.
Maltese: Mill-125 individwu li ħadu sehem, 80 (64%) kienu rġiel, l-età medjana kienet ta' 64 sena (firxa: 33 sa 87), u 110 (89%) kienu bojod.
English: GASTROINTESTINAL MOTILITY AGENTS
Maltese: MEDIĊINI TAL-MOVIMENT GASTROINTESTINALI Cisapride
English: In patients who resumed idelalisib at a lower dose, 26% had recurrence of ALT/AST elevation.
Maltese: F'pazjenti li reġgħu bdew idelalisib b'doża aktar baxxa, 26% kellhom rikorrenza ta' żieda fl-ALT/AST.
English: Expected effect of idelalisib on drug levels
Maltese: Effett mistenni ta' idelalisib fuq il-livelli tal-mediċina
English: The primary metabolite of idelalisib, GS-563117, is a strong CYP3A inhibitor.
Maltese: Il-metabolit primarju ta' idelalisib, GS-563117, hu inibitur qawwi ta' CYP3A.
English: • trazodone, a medicine used to treat depression
Maltese: • trazodone, mediċina li tintuża għat-trattament tad-dipressjoni
English: • dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer • oral or implanted hormonal contraceptives, used to prevent pregnancy
Maltese: • dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, mediċini li jintużaw għat-trattament tal-kanċer
English: There is a potential risk that idelalisib, via its major metabolite, GS-563117, may cause photosensitivity in treated patients.
Maltese: Hemm riskju potenzjali li idelalisib, permezz tal-metabolit maġġuri tiegħu, GS-563117, jista' jikkawża fotosensittività f'pazjenti ttrattati.
English: Effect of other medicinal products on idelalisib pharmacokinetics
Maltese: L-effett ta' prodotti mediċinali oħrajn fuq il-farmakokinetika ta' idelalisib
English: Infections and infestations Infections (including Pneumocystis jirovecii pneumonia and CMV)*
Maltese: Infezzjonijiet (inkluż pulmonite kkawżata minn
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.
Maltese: Idelalisib ma kienx karċinoġeniku f'esponimenti sa 1.4/7.9 darbiet (raġel/mara) fil-ġrieden meta mqabbel mal-esponiment f'pazjenti b'tumuri malinni ematoloġiċi li ngħataw id-doża rakkomandata ta' 150 mg darbtejn kuljum.
English: • colchicine, a medicine used to treat gout
Maltese: • colchicine, mediċina li tintuża għat-trattament tal-gotta
English: • inflammation of the lungs
Maltese: • infjammazzjoni tal-pulmuni
English: The Kaplan-Meier curve for PFS is provided in Figure 1.
Maltese: Il-kurva ta' Kaplan-Meier għal PFS hi pprovduta f'Figura 1.
English: PFS median (months) (95% CI) Hazard ratio (95% CI) ORR (95% CI)
Maltese: Medjan ta' PFS (xhur) (95% CI) Proporzjon ta' periklu (95% CI) ORR (95% CI)
English: * ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) based on the 2013 National Comprehensive Cancer Network (NCCN) response criteria and Cheson (2012).
Maltese: * ORR definit bħala l-proporzjon ta' individwi li kisbu rispons totali (CR - complete response) jew rispons parzjali (PR - partial response) abbażi tal-kriterji ta' rispons tan-National Comprehensive Cancer Network
English: Zydelig 150 mg film-coated tablets idelalisib
Maltese: Zydelig 150 mg pilloli miksija b'rita idelalisib
English: • clarithromycin, telithromycin, medicines used to treat bacterial infections
Maltese: • clarithromycin, telithromycin, mediċini li jintużaw għat-trattament ta' infezzjonijiet batterjali
English: Clinical monitoring is recommended for telithromycin.
Maltese: Monitoraġġ kliniku hu rakkomandat għal telithromycin.
English: In addition, 86 subjects from this study who were randomised to receive placebo + rituximab went on to receive idelalisib as a single agent in an extension study (study 312-0117).
Maltese: Flimkien ma' dan, 86 individwu minn dan l-istudju li kienu randomised biex jirċievu plaċebo + rituximab, komplew biex jirċievu idelalisib bħala sustanza unika fi studju ta' estensjoni (studju 312-0117).
English: The analyses of PFS, overall response rate (ORR) and lymph node response rate (LNR) were based on evaluation by an independent review committee (IRC).
Maltese: L-analiżi ta' PFS, ir-rata ta' rispons globali (ORR) u r-rata ta' rispons tal-glandoli limfatiċi (LNR) kienu bbażati fuq evalwazzjoni minn kumitat ta' analiżi indipendenti (IRC).
English: Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive in B-cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow.
Maltese: Idelalisib jinibixxi l-phosphatidylinositol 3-kinase p110δ (PI3Kδ), li huwa iperattiv f'tumuri malinni taċ-ċellula B u huwa importanti ħafna għal bosta passaġġi ta' sinjalazzjoni li jikkawżaw proliferazzjoni, sopravivenza, homing, u żamma ta' ċelluli malinni fit-tessuti limfatiċi u l-mudullun.
English: Quetiapine, pimozide
Maltese: MEDIĊINI ANTIPSIKOTIĊI/NEWROLETTIĊI Quetiapine, pimozide
English: Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).
Maltese: Zydelig hu indikat bħala monoterapija għat-trattament ta' pazjenti adulti b'limfoma follikulari (FLfollicular lymphoma) li hija reżistenti għal żewġ linji ta' trattament preċedenti (ara sezzjoni 4.4).
English: In studies up to 4 weeks in rats and dogs, hepatic necrosis was observed at 7 and 5 times the human exposure based on AUC, respectively.
Maltese: Fi studji li damu sa 4 ġimgħat fil-firien u fil-klieb, ġiet osservata nekrożi epatika f'7 u 5 darbiet l-esponiment uman ibbażat fuq l-AUC, rispettivament.
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.
Maltese: In vitro, l-inibizzjoni ta' CYP3A4 kienet irriversibbli, u r-ritorn għall-attività tal-enzima normali hi għalhekk mistennija li tieħu diversi jiem wara li jitwaqqaf l-għoti ta' idelalisib.
English: • amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
Maltese: • amlodipine, diltiazem, felodipine, nicardipine, nifedipine, mediċini li jintużaw għat trattament ta' pressjoni tad-demm għolja u problemi tal-qalb
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).
Maltese: L-ebda aġġustament fid-doża ta' clarithromycin mhu meħtieġ għal pazjenti b'funzjoni normali tal-kliewi jew b'indeboliment ħafif tal-kliewi (tneħħija tal-krejatinina [CrCl] ta' 60-90 mL/min).
English: No patients with severe hepatic impairment were included in clinical studies of idelalisib.
Maltese: Ebda pazjent b'indeboliment epatiku sever ma ġie inkluż fi studji kliniċi ta' idelalisib.
English: Zydelig 100 mg film-coated tablets idelalisib
Maltese: Zydelig 100 mg pilloli miksija b'rita idelalisib
English: For patients with CrCl < 60 mL/min, alternative antibacterials should be considered.
Maltese: Għal pazjenti b'CrCl ta' < 60 mL/min, antibatterjali alternattivi għandhom jiġu kkunsidrati.