FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be used with weak CYP3A inhibitors (e.g. amlodipine, cilostazol, fluvoxamine, goldenseal, isoniazid, ranitidine, ranolazine) in PMs.
Maltese: F'PMs, l-inibituri dgħajfa ta' CYP3A (e.ż. amlodipine, cilostazol, fluvoxamine, goldenseal, isoniazid,
English: After repeated 84 mg twice daily doses of eliglustat in non-PMs, concomitant administration with repeated 400 mg once daily doses of ketoconazole, a strong inhibitor of CYP3A, resulted in a 3.8 and 4.3-fold increase in eliglustat Cmax and AUC0-12, respectively; similar effects would be expected for other strong inhibitors of CYP3A (e.g. clarithromycin, ketoconazole, itraconazole, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, boceprevir).
Maltese: Wara dożi ripetuti ta' 84 mg ta' eliglustat darbtejn kuljum f'pazjenti li mhumiex PMs, l-għoti fl-istess ħin ta'dożi ripetuti ta' 400 mg ta' ketoconazole darba kuljum, inibitur qawwi ta' CYP3A, wassal għal żieda fis-Cmax u l- AUC0-12 ta' eliglustat ta' 3.8 u 4.3-darbiet, rispettivament; huma mistennija effetti simili għal inibituri qawwija oħra ta' CYP3A (eż. clarithromycin, ketoconazole, itraconazole, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, boceprevir).
English: No clinically significant QTc prolonging effect of eliglustat was observed for single doses up to 675 mg.
Maltese: Ma kien osservat l-ebda effett klinikament sinifikanti ta' eliglustat fuq it-titwil tal-QTc għal dożi uniċi sa 675 mg.
English: Table 3: Change from baseline to year 8 in study 304
Maltese: Tabella 3: Bidla mil-linja bażi sa sena 8 fl-istudju 304
English: Composite Stability Endpoint Patients who are Stable on Cerdelga (%)
Maltese: Endpoint Kompost ta' Stabbiltà Pazjenti li huma Stabbli b'Cerdelga (%)
English: One patient (6%) received a further dose escalation to 127 mg twice daily.
Maltese: Pazjent wieħed (6%) irċieva żieda oħra fid-doża għal 127 mg darbtejn kuljum.
English: Percentage Change in Spleen Volume MN (%) (primary endpoint) Absolute Change in Haemoglobin Level (g/dL) (secondary endpoint) Percentage Change in Liver Volume MN (%) (secondary endpoint) Percentage Change in Platelet Count (%) (secondary endpoint) MN = Multiples of Normal, CI = confidence interval a At baseline, mean spleen volumes were 12.5 and 13.9 MN in the placebo and Cerdelga groups, respectively, and mean liver volumes were 1.4 MN for both groups.
Maltese: Bidla perċentwali fl-Għadd tal-Plejtlits (%) (endpoint sekondarju) MN = Multiples of Normal (Multipli tan-Normal), CI = confidence interval (intervall ta' fiduċja) a Fil-linja bażi, il-volumi medji tal-milsa kienu ta' 12.5 u 13.9 MN fil-grupp tal-plaċebo u ta' Cerdelga, rispettivament, u l-volumi medji tal-fwied kienu ta' 1.4
English: Embryofoetal development in rats and rabbits was not affected up to clinically relevant exposure (based on AUC).
Maltese: Liżvilupp embrijofetali fil-firien u l-fniek ma kienx affettwat sa espożizzjoni klinikament rilevanti (abbażi tal-AUC).
English: o Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).
Maltese: o Cerdelga huwa indikat għall-kura fit-tul ta' pazjenti adulti bil-marda ta' Gaucher tat-tip 1 (GD1).
English: • phenytoin - anti-epileptic (used to treat epilepsy and seizures)
Maltese: • phenytoin - anti epilettiku (użat fil-kura tal-epilessija u ta' konvulżjonijiet)
English: • are taking an antiarrhythmic medicine (used to treat irregular heart beat) like quinidine,
Maltese: • qed tieħu mediċina antiarritmika (użata għall-kura ta' taħbit tal-qalb irregolari) bħal quinidine,
English: o In CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment, Cerdelga is contraindicated.
Maltese: o F'metabolizzaturi estensivi ta' CYP2D6 (EMs) b'indeboliment epatiku sever, Cerdelga huwa kontraindikat.
English: Initiation of therapy: CYP2D6 genotyping
Maltese: Il-bidu tat-terapija: evalwazzjoni tal-ġenotip ta' CYP2D6
English: Eliglustat is a potent and specific inhibitor of glucosylceramide synthase, and acts as a substrate reduction therapy (SRT) for GD1.
Maltese: Eliglustat huwa inibitur qawwi u speċifiku ta' glucosylceramide synthase, u jaġixxi bħala terapija li tnaqqas is-substrat (substrate reduction therapy, SRT) għal GD1.
English: Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Maltese: Cerdelga huwa indikat għall-kura fit-tul ta' pazjenti adulti bil-marda ta' Gaucher tat-tip 1 (Gaucher disease type 1, GD1), li huma metabolizzaturi dgħajfa (poor metabolisers, PMs), metabolizzaturi intermedji (intermediate metabolisers, IMs) jew metabolizzaturi estensivi (extensive metabolisers, EMs) ta' CYP2D6.
English: - If you are an extensive metaboliser and you have severely reduced liver function.
Maltese: - Jekk inti metabolizzatur estensiv u għandek il-funzjoni tal-fwied li hija severament imnaqqsa.
English: Date of first authorisation: 19 January 2015 Date of latest renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' Jannar, 2015
English: After repeated 127 mg twice daily doses of eliglustat in non-PMs, concomitant administration of repeated 600 mg once daily doses of rifampicin (a strong inducer of CYP3A as well as the efflux transporter P-gp) resulted in an approximately 85% decrease in eliglustat exposure.
Maltese: Wara dożi ripetuti ta' 127 mg ta' eliglustat darbtejn kuljum f'pazjenti li mhumiex PMs, l-għoti fl-istess ħin ta' dożi ripetuti ta' 600 mg ta' rifampicin darba kuljum (stimulatur qawwi ta' CYP3A kif ukoll tattrasportatur tal-effluss P-gp) wassal għal tnaqqis ta' madwar 85% fl-espożizzjoni għal eliglustat.
English: After a single 84 mg dose, eliglustat Cmax and AUC were 1.2- and 1.2-fold higher in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment, and 2.8- and 5.2-fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs).
Maltese: Wara doża waħda ta' 84 mg , eliglustat Cmax u AUC kienu 1.2- u 1.2-darbiet ogħla f'metabolizzaturi estensivi (EMs) ta' CYP2D6 b'indeboliment epatiku ħafif u 2.8- u 5.2-darbiet ogħla f'metabolizzaturi estensivi (EMs) ta' CYP2D6 b'indeboliment epatiku moderat meta mqabbla ma' metabolizzaturi estensivi (EMs) ta' CYP2D6 b'saħħithom.
English: Percentage Change in Liver Volume MN (%)
Maltese: Volum tal-Fwied MN (%)
English: • imatinib - anticancer (used to treat cancer)
Maltese: • imatinib - kontra l-kanċer (użat fil-kura tal-kanċer)
English: Fifteen (79%) of these patients received a dose escalation to 84 mg eliglustat twice daily; 4 (21%) patients continued to receive 42 mg twice daily.
Maltese: Ħmistax (79%) minn dawn il-pazjenti rċevew żieda fid-doża sa 84 mg eliglustat darbtejn kuljum; 4 (21%) pazjenti komplew jirċievu 42 mg darbtejn kuljum.
English: After 12 months of treatment, the percentage of patients meeting the primary composite endpoint (composed of all four components mentioned in Table 4) was 84.8% [95% confidence interval 76.2% - 91.3%] for the Cerdelga group compared to 93.6% [95% confidence interval 82.5% - 98.7 %] for the Cerezyme group.
Maltese: 3%] għall-grupp ta' Cerdelga meta mqabbel ma' 93.6% [95% intervall ta' konfidenza 82.5% - 98.7 %] għall-grupp ta' Cerezyme.
English: Clinical experience in CYP2D6 poor metabolisers (PMs) and ultra-rapid metabolisers (URMs)
Maltese: L-esperjenza klinika f'metabolizzaturi dgħajfa (PMs) u f'metabolizzaturi ultra-rapidi (URMs) ta'
English: Nonclinical studies demonstrated a wide distribution of eliglustat to tissues, including bone marrow.
Maltese: Studji mhux kliniċi wrew distribuzzjoni wiesgħa ta' eliglustat lejn it-tessuti, inkluż il-mudullun.
English: At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, boceprevir) would increase the Cmax and AUC0-24 of eliglustat 4.3- and 6.2-fold.
Maltese: B'dożaġġ ta' 84 mg darba kuljum ta' eliglustat f'PMs, huwa previst li l-użu fl-istess ħin ta' inibituri qawwijin ta' CYP3A (eż. ketoconazole, clarithromycin, itraconazole, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, boceprevir) jżid is-Cmax u l- AUC0-24 ta' eliglustat b'4.3 u 6.2 darbiet.
English: After repeated oral doses of 84 mg eliglustat twice daily, eliglustat elimination half-life is approximately 4-7 hours in non-PMs and 9 hours in PMs.
Maltese: Wara dożi orali ripetuti ta' 84 mg eliglustat darbtejn kuljum, il-half-life tal-eliminazzjoni ta' eliglustat hija ta' madwar 4-7 sigħat f'dawk li mhumiex PMs u 9 sigħat f'PMs.
English: Sixteen patients had an efficacy endpoint assessment at year 8.
Maltese: Sittax-il pazjent kellhom evalwazzjoni tal-punt finali ta' effikaċja fit-8 sena.
English: Spleen Volume
Maltese: Bidla milLinja
English: • colchicine - used to treat gout
Maltese: • colchicine - użat fil-kura tal-gotta
English: After a single 50 mg dose of metoprolol, a CYP2D6 substrate, concomitant administration of repeated 127 mg twice daily doses of eliglustat resulted in a 1.5- and 2.1-fold increase in metoprolol Cmax and AUC, respectively.
Maltese: Wara doża unika ta' 50 mg ta' metoprolol, substrat ta' CYP2D6, l-għoti fl-istess ħin ta' dożi ripetuti ta' 127 mg ta' eliglustat darbtejn kuljum wassal għal żieda ta' 1.5 u 2.1 darbiet fis-Cmax u l-AUC ta'
English: While pressing your thumb and finger together at one end of the sleeve (1) gently pull the blister/wallet out to open the sleeve (2).
Maltese: Filwaqt li tagħfas il-behem u s-saba' flimkien f'tarf tal-qoxra (1) iġbed bil-mod listrixxa/kartiera barra mill-qoxra (2).
English: These include certain antidepressants (tricyclic antidepressants, e.g. nortriptyline, amitriptyline, imipramine, and desipramine), phenothiazines, dextromethorphan and atomoxetine).
Maltese: amitriptyline, imipramine u desipramine), phenothiazines, dextromethorphan u atomoxetine.
English: Each capsule contains 84 mg of eliglustat (as tartrate)
Maltese: Kull kapsula fiha 84 mg ta' eliglustat (bħala tartrate)
English: Headache*, dizziness*, dysgeusia
Maltese: Uġigħ ta' ras*, sturdament*, disgewsja
English: Cerdelga contains the active substance eliglustat which decreases the production of glucosylceramide, thereby preventing its buildup.
Maltese: Cerdelga fih is-sustanza attiva eliglustat li tnaqqas il-produzzjoni ta' glucosylceramide,
English: Eighteen patients completed 8 years of treatment.
Maltese: Tmintax-il pazjent temmew 8 snin ta' kura.
English: CYP2D6 ultra-rapid metabolisers (URMs) and indeterminate metabolisers Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or indeterminate metabolisers (see section 4.4).
Maltese: Metabolizzaturi ultra-rapidi (ultra-rapid metabolisers, URMs), u metabolizzaturi indeterminati ta' CYP2D6
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of moderate CYP2D6 inhibitors (e.g. duloxetine, terbinafine, moclobemide, mirabegron, cinacalcet, dronedarone) would increase eliglustat exposure approximately up to 4-fold.
Maltese: F'dożaġġ ta' 84 mg darbtejn kuljum b'eliglustat f'pazjenti li mhumiex PMs, huwa previst li l-użu flistess ħin ta' inibituri moderati ta' CYP2D6 (eż. duloxetine, terbinafine, moclobemide, mirabegron, cinacalcet,dronedarone) se jżid l-espożizzjoni għal eliglustat sa madwar 4 darbiet.
English: After oral administration, the majority of the administered dose is excreted in urine (41.8%) and faeces (51.4%), mainly as metabolites.
Maltese: Wara l-għoti orali, il-maġġoranza tad-doża mogħtija titneħħa fl-awrina (41.8%) u flippurgar (51.4%), prinċipalment bħala metaboliti.
English: Five Cerdelga-treated patients (26%) achieved a reduction of at least 2 points in the BMB score.
Maltese: Ħames pazjenti ttrattati b'Cerdelga (26 %) kisbu tnaqqis ta' mill-inqas 2 punti fil-punteġġ totali tal-BMB.
English: o In the printing ink: shellac, black iron oxide (E172), propylene glycol and ammonia solution, concentrated.
Maltese: o Fl-inka tal-istampar: shellac, iron oxide iswed (E172), propylene glycol u soluzzjoni ta'
English: In the Cerdelga group 3 (15%) patients received a starting dose of 42 mg eliglustat twice daily during the 9-month primary analysis period and 17 (85%) patients received a dose escalation to 84 mg twice daily based on plasma trough concentration.
Maltese: Fil-grupp ta' Cerdelga 3 (15%) pazjenti rċevew doża inizjali ta' 42 mg eliglustat darbtejn kuljum matul il-perjodu tal-analiżi primarja ta' 9 xhur u 17 (85%)
English: Cerdelga patients and 3 of 3 Cerezyme patients remained within therapeutic goals for GD1.
Maltese: 3 mit-3 pazjenti fuq Cerezyme baqgħu fi ħdan il-miri terapewtiċi għal GD1.
English: After repeated 84 mg once daily doses of Cerdelga, Cmax and AUC0-24 are predicted to be 3.1- and 3.2fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs ) receiving Cerdelga 84 mg twice daily (see sections 4.2 and 4.4).
Maltese: Wara dożi ripetuti ta' 84 mg darbtejn kuljum ta' Cerdelga, Cmax u AUC0-12 huma mistennija li jkunu 3.1- u 3.2- darbiet ogħla f'metabolizzaturi estensivi (EMs) ta' CYP2D6 b'indeboliment epatiku moderat meta mqabbla ma' metabolizzaturi estensivi (EMs) ta' CYP2D6 b'saħħithom li qed jirċievu Cerdelga 84 mg darbtejn kuljum (ara sezzjonijiet 4.2 u 4.4).
English: The effect of severe hepatic impairment was not studied in subjects with any CYP2D6 phenotype (see sections 4.2, 4.3 and 4.4).
Maltese: L-effett ta' indeboliment epatiku sever ma ġiex studjat f'suġġetti b'kwalunkwe fenotip CYP2D6 (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: Reports from the subregistry are to be submitted with each PSUR.
Maltese: Rapporti mis sottoreġistru għandhom jiġu sottomessi ma' kull PSUR.
English: After intravenous administration, eliglustat total body clearance was 86 L/h.
Maltese: Wara l-għoti ġol-vina, it-tneħħija totali ta' eliglustat mill-ġisem kienet ta' 86 L/h.
English: Cerdelga is indicated in patients who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Maltese: Cerdelga huwa indikat f'pazjenti li huma metabolizzaturi dgħajfa (PMs - poor metabolisers), metabolizzaturi intermedji (IMs - intermediate metabolisers) jew metabolizzaturi estensivi (EMs - extensive metabolisers) ta' CYP2D6.
English: Pivotal study of Cerdelga in treatment-naïve GD1 patients - study 02507(ENGAGE) Study 02507 was a randomized, double-blind, placebo-controlled, multicenter clinical study in 40 patients with GD1.
Maltese: L-istudju 02507 kien studju kliniku multiċentriku, magħmul b'mod arbitrarju, bi blindaġġ doppju,
English: After 18 and 30 months of treatment, BMB score had decreased by a mean 2.2 points (n=18) and 2.7 (n=15), respectively for the patients originally randomised to Cerdelga, compared to a mean decrease of 1 point (n=20) and 0.8 (n=16) in those originally randomised to placebo.
Maltese: 2.7 (n=15), rispettivament għall-pazjenti li oriġinarjament ingħataw b'mod arbitrarju Cerdelga, meta mqabbel ma' tnaqqis medju ta' punt wieħed (n=20) u 0.8 (n=16) f'dawk li oriġinarjament ingħataw b'mod arbitrarju plaċebo.
English: Year 3
Maltese: 3 snin
English: p valueb
Maltese: Valur filLinja
English: In CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment (Child-Pugh class B), eliglustat is not recommended (see sections 4.4 and 5.2).
Maltese: F'metabolizzaturi estensivi ta' CYP2D6 (EMs) b'indeboliment tal-fwied moderat (Child-Pugh klassi B), eliglustat mhux irrakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: ** All patients transitioned to Cerdelga treatment after 52 weeks a The stability criteria based on changes between baseline and 12 months: haemoglobin level ≤1.5 g/dL decrease, platelet count ≤25% decrease, liver volume ≤20% increase, and spleen volume ≤25% increase.
Maltese: ** Il-pazjenti kollha għaddew għal fuq trattament b'Cerdelga wara 52 ġimgħa a Il-kriterji ta' stabbiltà bbażati fuq il-bidliet bejn il-linja bażi u t-12-il xahar: tnaqqis fil-livell tal-emoglobina ta' ≤1.5 g/dL, tnaqqis fl-għadd tal-plejtlits ta' ≤25%, żieda fil-volum tal-fwied ta' ≤20%, u żieda fil-volum tal-milsa ta' ≤25%.
English: In rat repeated dose toxicity studies, seminiferous epithelial degeneration and segmental hypoplasia of the testes was seen at 10-fold of predicted human exposure based on AUC.
Maltese: Fi studji ta' tossiċità b'dożi ripetuti fuq il-firien, dehru deġenerazzjoni seminifera epiteljali u ipoplażja segmentali tattestikoli f'10 darbiet l-espożizzjoni prevista fil-bniedem abbażi tal-AUC.
English: Eliglustat is an inhibitor of P-gp and CYP2D6 in vitro; concomitant administration of eliglustat with P-gp or CYP2D6 substrate substances may increase the plasma concentration of those substances.
Maltese: Eliglustat huwa inibitur ta' P-gp u ta' CYP2D6 in vitro; lgħoti fl-istess ħin ta' eliglustat ma' sustanzi li huma substrati ta' P-gp jew ta' CYP2D6 jista' jżid ilkonċentrazzjoni ta' dawn is-sustanzi fil-plasma.
English: The combination of these medicines will interfere with your body's ability to break down Cerdelga and this can result in higher levels of the active substance in your blood (see the section ‘Other medicines and Cerdelga' for an expanded list of medicines).
Maltese: Mediċini ta' dan it-tip se jinterferixxu mal-abilità ta' ġismek li jkisser Cerdelga u dan jista' jirriżulta f'livelli ogħla tas-sustanza attiva f'demmek (ara s-sezzjoni “Mediċini oħra u Cerdelga”għal lista estiża ta' mediċini).
English: After intravenous administration, the volume of distribution was 816 L, suggesting wide distribution to tissues in humans.
Maltese: Wara l-għoti ġol-vina, il-volum tad-distribuzzjoni kien ta' 816 L,
English: After repeated 84 mg twice daily doses of eliglustat in non-PMs, concomitant administration with repeated 30 mg once daily doses of paroxetine, a strong inhibitor of CYP2D6, resulted in a 7.3- and 8.9-fold increase in eliglustat Cmax and AUC0-12, respectively.
Maltese: Wara dożi ripetuti ta' 84 mg ta' eliglustat darbtejn kuljum f'pazjenti li mhumiex PMs, l-għoti fl-istess ħin ta' dożi ripetuti ta' 30 mg ta' paroxetine darba kuljum, inibitur qawwi ta' CYP2D6, wassal għal żieda fis-Cmax u l-AUC0-12 ta' eliglustat ta' 7.3- u ta' 8.9-darbiet, rispettivament.
English: • have an irregular, or abnormal heart beat, inluding a heart condition called long QT syndrome.
Maltese: • għandek taħbit tal-qalb irregolari, jew mhux normali, inkluż kondizzjoni tal-qalb imsejħa sindromu tal-QT imtawwal.
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (tista' taffettwa sa persuna 1 minn kull 10):
English: Change in Spleen Volume MN (%)*
Maltese: Volum tal-Fwied MN (%)(endpoint sekondarju)
English: Three (17%) patients continued to receive 42 mg twice daily.
Maltese: Tliet (17%) pazjenti baqgħu jirċievu 42 mg darbtejn kuljum.
English: Spleen Volume Patients with stable spleen volume (%)*
Maltese: Pazjenti b'volum stabbli tal-fwied (%)
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattożju, id-defiċjenza totali ta' lactase jew b'malassorbiment tal-glukożju-galattożju m'għandhomx jieħdu din il-mediċina.
English: Cerdelga contains the active substance eliglustat and is used for the long term treatment of adult patients with Gaucher disease type 1.
Maltese: Cerdelga fiha s-sustanza attiva eliglustat u tintuża għal kura fit-tul ta' pazjenti adulti bil-marda ta' Gaucher tat-tip 1.
English: In study 02607, lumbar spine and femur BMD T- and Z-scores were maintained within the normal range in patients treated with Cerdelga for up to 4 years.
Maltese: Fl-istudju 02607, il-punteġġi-T u Z tal-BMD tal-ispina lumbari u tal-wirk (l-għadma tal-koxxa tas sieq) baqgħu jinżammu fil-marġni normali fil-pazjenti kkurati b'Cerdelga għal 4 snin.
English: Limited data are available in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment.
Maltese: Hemm tagħrif limitat f'metabolizzaturi estensivi (EMs) ta' CYP2D6 b'indeboliment moderat talfwied.
English: At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of moderate CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase the Cmax and AUC0-24 of eliglustat 2.4- and 3.0-fold, respectively.
Maltese: B'dożaġġ ta' 84 mg darba kuljum ta' eliglustat f'PMs, huwa previst li l-użu fl-istess ħin ta' inibituri moderati ta' CYP3A (eż. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) jżid is-Cmax u l- AUC0-24 ta' eliglustat b'2.4 u 3 darbiet, rispettivament.
English: The overall adverse reaction profile of Cerdelga is based on 1400 patient-years of treatment exposure and pooled results from the primary analysis periods and extension periods of two pivotal Phase 3 studies (ENGAGE and ENCORE), one 8-year, long term Phase 2 study (Study 304) and one supporting Phase 3b study (EDGE).
Maltese: żewġ studji prinċipali ta' Fażi 3 (ENGAGE u ENCORE), studju wieħed fit-tul ta'Fażi 2 li dam 8-snin (Studju 304) u studju wieħed ta' support ta' Fażi 3b (EDGE).
English: In poor metabolisers (PMs):
Maltese: F'metabolizzaturi dgħajfa (PMs):
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that the concomitant use of strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors would increase Cmax and AUC0-12 up to 17- and 25-fold, respectively.
Maltese: B'dożaġġ ta' 84 mg darbtejn kuljum ta' eliglustat f'pazjenti li mhumiex PMs, huwa previst li l-użu flistess ħin ta' inibituri qawwijin jew moderati ta' CYP2D6 u inibituri qawwijin jew moderati ta' CYP3A jżid is-Cmax u l- AUC0-12 ta' eliglustat sa 17 u 25 darba, rispettivament.
English: Data indicates that no dosage adjustment is considered necessary (see sections 5.1 and 5.2).
Maltese: Id-dejta tindika li mhux ikkunsidrat bżonnjuż li jkun hemm aġġustament fid-dożaġġ (ara sezzjonijiet 5.1 u 5.2).
English: After a single 84 mg dose, eliglustat Cmax and AUC were similar in CYP2D6 extensive metabolisers (EMs) with severe renal impairment and healthy CYP2D6 extensive metabolisers (EMs).
Maltese: Wara doża waħda ta' 84 mg , eliglustat Cmax u AUC kienu simili f'metabolizzaturi estensivi (EMs) ta' CYP2D6 b'indeboliment renali sever u metabolizzaturi estensivi (EMs) ta' CYP2D6 b'saħħithom.
English: Additionally, in a clinical trial in GD1 patients stabilised on enzyme replacement therapy (ERT) (i.e. having already achieved therapeutic goals on ERT prior to initiating Cerdelga treatment), plasma GL-1 levels were normal in most patients and decreased upon Cerdelga treatment.
Maltese: Barra minn hekk, fi prova klinika f'pazjenti b'GD1 stabilizzati fuq terapija ta' sostituzzjoni tal-enzimi (enzyme replacement therapy, ERT) (jiġifieri li diġà kienu laħqu l-għanijiet terapewtiċi fuq ERT qabel ma bdew il-kura b'Cerdelga), il-livelli ta' GL-1 fil-plasma kienu normali f'ħafna mill-pazjenti u naqsu wara kura b'Cerdelga.
English: The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Maltese: o Id-doża rrakkomandata hija 84 mg eliglustat darbtejn kuljum f'metabolizzaturi intermedji (IMs) u metabolizzaturi estensivi (EMs) ta' CYP2D6.
English: Reversible inhibition of spermatogenesis was observed in the rat at 10-fold of predicted human exposure based on AUC, a systemically toxic dose.
Maltese: Inibizzjoni riversibbli tal-ispermatoġenesi kienet osservata fil-firien f'10 darbiet l espożizzjoni prevista fil-bniedem abbażi tal-AUC, doża sistemikament tossika.