FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and Xermelo
Maltese: Mediċini oħra u Xermelo
English: In patients treated at 500 mg tid (twice the recommended dose), a median accumulation ratio based on AUC0-4h of 1.095 (minimum, 0.274; maximum, 11.46; n=16; week 24) was observed, with a high inter-subject variability (%CV = 141.8%).
Maltese: F'pazjenti kkurati b'500 mg tid (darbtejn id-doża rakkomandata), proporzjon ta' akkumulazzjoni medjan ibbażat fuq AUC0-4h ta' 1.095 (minimu, 0.274; massimu, 11.46; n=16; Ġimgħa 24) ġie osservat, b'varjabilità għolja bejn l-individwi (%CV = 141.8%).
English: In a specific clinical DDI study, the Cmax and AUC of fexofenadine (a P-gp and MRP-2 substrate) increased by 16% when a single 180 mg dose of fexofenadine was co-administered orally with a dose of telotristat ethyl 500 mg administered tid (twice the recommended dose) for 5 days.
Maltese: Fi studju kliniku speċifiku DDI, is-Cmax u l-AUC ta' fexofenadine (sottostrat ta' P-gp u MRP-2) żdied b'16% meta doża waħda ta' 180 mg ta' fexofenadine ingħatat flimkien oralment ma' doża ta' telotristat ethyl 500 mg mogħtija tid (darbtejn id-doża rakkomandata) għal 5 ijiem.
English: Flatulence was seen in 5.7% of patients (4/70) and 1.4% (1/71) in the telotristat ethyl 250 mg and placebo groups, respectively.
Maltese: Gass fl-istonku ġie osservat f'5.7% tal-pazjenti (4/70) u 1.4% (1/71) fil-gruppi ta' telotristat ethyl 250 mg u tal-plaċebo, rispettivament.
English: The mean age was 63 years (range 35 to 84 years), 55% were male and 97% were white.
Maltese: Letà medja kienet ta' 63 sena (medda minn 35 sa 84 sena), 55% kienu rġiel u 97% kienu bojod.
English: In vitro, telotristat ethyl inhibited CES2 with an IC50 approximately of 6.4 μM.
Maltese: In vitro, telotristat ethyl inibixxa CES2 b'IC50 ta' madwar 6.4 μM.
English: In a food effect study administration of telotristat ethyl 500 mg with a high-fat meal resulted in higher exposure to the parent compound (Cmax, AUC0-tlast, and AUC0-∞ being 112%, 272%, and 264% higher, respectively compared with the fasted state) and its active metabolite (Cmax, AUC0-tlast, and AUC0-∞, 47%, 32%, and 33% higher, respectively compared with the fasted state).
Maltese: Fi studju dwar l-effett tal-ikel, l-għoti ta' telotristat ethyl 500 mg ma' ikla b'ħafna xaħam, irriżulta f'esponiment ogħla għall-kompost ewlieni (Cmax, AUC0-tlast, u AUC0-∞ li kienu 112%, 272%, u 264% ogħla, rispettivament, meta mqabbla mal-istat sajjem) u l-metabolit attiv tiegħu (Cmax, AUC0-tlast, u AUC0-∞, 47%, 32%, u 33% ogħla, rispettivament, meta mqabbla mal-istat sajjem).
English: Following administration of 500 mg tid, the apparent terminal half-life was approximately 11 hours.
Maltese: Wara l-għoti ta' 500 mg tid, il-half-life terminali apparenti kienet ta' madwar 11-il siegħa.
English: c Faecaloma has only been observed in a clinical study at a dosage of 500mg tid (twice the recommended dose).
Maltese: c Fekaloma kienet osservata biss fi studju kliniku f'dożaġġ ta' 500 mg tid (darbtejn id-doża rakkomandata).
English: Oedema peripheral, Pyrexia a Abdominal pain (including upper and lower abdominal pain) b Gamma-glutamyl transferase increased (including preferred terms of gamma-glutamyl transferase increased, gamma-glutamyl transferase, and liver function test abnormal / hepatic enzyme increased for which gamma-glutamyl transferase was increased).
Maltese: Żieda f'gamma-glutamyl transferase (li jinkludi termini ppreferuti ta' żieda f'gamma-glutamyl transferase, gamma-glutamyl transferase, u test tal-funzjoni tal-fwied b'riżultat anormali/żieda flenzimi tal-fwied li għalihom żdiedu l-gamma-glutamyl transferase).
English: There were 40% patients (10/25) with durable response (as defined in Table2) in the telotristat ethyl 250 mg group, versus 0% in the placebo group (0/26) (p=0.001).
Maltese: Kien hemm 40% tal-pazjenti (10/25) b'rispons li dam fit-tul (kif definit f'Tabella 2) fil-grupp ta' telotristat ethyl 250 mg, kontra 0% fil-grupp tal-plaċebo (0/26) (p=0.001).
English: In vitro loperamide (CES2 inhibitor) had a moderate effect on the metabolism of telotristat ethyl, reducing the formation of telotristat by <30% (see section 4.5).
Maltese: In vitro, loperamide (inibitur ta' CES2) kellu effett moderat fuq il-metaboliżmu ta' telotristat ethyl, u naqqas il-formazzjoni ta' telotristat b'<30% (ara sezzjoni 4.5).
English: Concomitant use of Xermelo may decrease the efficacy of medicinal products that are CYP2B6 substrates (e.g. valproic acid, bupropion, sertraline) by decreasing their systemic exposure.
Maltese: L-użu konkomitanti ta' Xermelo jista' jnaqqas leffikaċja ta' prodotti mediċinali li huma substrati ta' CYP2B6 (eż. valproic acid, bupropion, sertraline) billi jnaqqas l-esponiment sistemiku tagħhom.
English: For clinical management of elevated hepatic enzymes, see section 4.4.
Maltese: Għal immaniġġjar kliniku ta' livell għoli ta' enzimi tal-fwied, ara sezzjoni 4.4.
English: In patients treated at 250 mg tid, a slight accumulation of telotristat levels was observed with a median accumulation ratio based on AUC0-4h of 1.55 [minimum, 0.25; maximum, 5.00; n=11; week 12], with a high inter-subject variability (%CV = 72%).
Maltese: F'pazjenti kkurati b'250 mg tid, akkumulazzjoni żgħira ta' livelli ta' telotristat ġiet osservata bi proporzjon ta' akkumulazzjoni medjan ibbażat fuq AUC0-4h ta' 1.55 [minimu, 0.25; massimu, 5.00; n=11; Ġimgħa 12], b'varjabilità għolja bejn l-individwi (%CV=72%).
English: CYP2B6 substrates
Maltese: Substrati ta' CYP2B6
English: Distribution Both telotristat ethyl and its active metabolite are > 99% bound to human plasma proteins.
Maltese: Distribuzzjoni Kemm telotristat ethyl u l-metabolit attiv tiegħu jeħlu b'>99% mal-proteini tal-plażma tal-bniedem.
English: Telotristat ethyl 250 mg showed that stool consistency, as measured by Bristol Stool Form Scale, was improved compared with placebo.
Maltese: Telotristat ethyl 250 mg wera li l-konsistenza tal-ippurgar, kif imkejla mill-Bristol Stool Form Scale, tjiebet meta mqabbla mal-plaċebo.
English: In rats decrease in brain serotonin (5-HT) was observed at doses≥1,000 mg/kg/day of telotristat etiprate per os.
Maltese: Fil-firien, tnaqqis tas-serotonin fil-moħħ (5-HT) ġie osservat f'dożi ta' ≥1,000 mg/kg/jum ta' telotristat etiprate kull os.
English: When 3 mg midazolam was coadministered orally after 5-day treatment with telotristat ethyl 500 mg tid (twice the recommended dose), the mean Cmax, and AUC0-inf for midazolam were decreased by 25%, and 48%, respectively, compared with administration of midazolam alone.
Maltese: Meta 3 mg ta' midazolam ingħataw flimkien oralment wara 5 ijiem ta' kura b'telotristat ethyl 500 mg tid (darbtejn id-doża rakkomandata), il-medja tas-Cmax, u AUC0-inf għal midazolam tnaqqsu b'25%, u 48%, rispettivament, meta mqabbla mal-għoti ta' midazolam waħdu.
English: Effect of other medicinal products on Xermelo
Maltese: L-effett ta' prodotti mediċinali oħra fuq Xermelo
English: Following a single 500 mg oral dose of 14C-telotristat ethyl, approximately 93% of the dose was recovered.
Maltese: Wara doża orali waħda ta' 500 mg 4C-telotristat ethyl, madwar 93% tad-doża ġiet irkuprata.
English: • Swelling (build-up of fluid in the body)
Maltese: • Nefħa (akkumulazzjoni ta' fluwidu fil-ġisem)
English: How to store Xermelo 6.
Maltese: Kif taħżen Xermelo 6.
English: Adverse reactions reported in a pooled safety dataset of 70 patients with carcinoid syndrome receiving telotristat ethyl 250 mg tid in combination with SSA therapy in placebo-controlled clinical trials are listed in Table 1.
Maltese: Reazzjonijiet avversi rrappurtati f'dataset miġbur dwar is-sigurtà ta' 70 pazjent b'sindrome karċinojde li kienu qed jirċievu telotristat ethyl 250 mg tid flimkien ma' terapija b'SSA fi provi kliniċi kkontrollati bi plaċebo huma elenkati f'Tabella 1.
English: Moreover, in the long-term safety study (LX1606.1-302-CS), the incidence of depression was 21% and there is a probable biological mechanism that telotristat reduces the production of serotonin that may lead to symptoms of depression.
Maltese: Barra minn hekk, fl-istudju dwar is-sigurtà fit-tul (LX1606.1-302-CS), l-inċidenza ta' depressjoni kienet ta' 21% u hemm mekkaniżmu bijoloġiku probabbli li telotristat inaqqas ilproduzzjoni ta' serotonin u dan jista' jwassal għal sintomi ta' depressjoni.
English: In a phase 3 study of similar design (TELECAST), a total of 76 patients were evaluated for efficacy.
Maltese: Fi studju ta' Fażi 3 b'disinn simili (TELECAST), total ta' 76 pazjent ġew evalwati għall-effikaċja.
English: Number of Patients Baseline Meana (SD)
Maltese: Numru ta' pazjenti Medja fil-linja bażi (SD)
English: Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Maltese: Xermelo huwa indikat għall-kura ta' dijarea tas-sindrome karċinojde flimkien ma' terapija b'analogi ta' somatostatin (SSA, somatostatin analogue) f'adulti li mhumiex ikkontrollati b'mod adegwat minn terapija b'SSA.
English: P-glycoprotein (P-gp) and Multi-drug Resistance associated Protein 2 (MRP-2) In vitro telotristat ethyl inhibited P-gp, but its active metabolite did not at the clinically relevant concentrations.
Maltese: P-glikoproteina (P-gp) u Proteina Assoċjata mar-Reżistenza għal Ħafna Mediċini 2 (MRP-2, Multidrug Resistance associated Protein 2)
English: Note: This figure plots the arithmetic mean and 95% confidence limits (CL) (based on normal approximation) of the change from Baseline in the number of daily bowel movements (counts/day) averaged at each week.
Maltese: Nota: Din il-figura turi l-medja aritmetika u l-imiti ta' kunfidenza ta' 95% (95% confidence limits (CL)) (ibbażati fuq approssimazzjoni normali) tal-bidla mil-Linja
English: In the subjects with severe to moderate renal impairment, an increase (1.3- fold) in peak exposure Cmax of telotristat ethyl and an increase (<1.52- fold) in plasma exposure (AUC) and Cmax of its active metabolite telotristat was observed compared to healthy to mildly impaired subjects.
Maltese: Fl-individwi b'indeboliment sever għal moderat tal-kliewi, ġew osservati żieda (1.3 darbiet) fl-ogħla esponiment Cmax għal telotristat ethyl u żieda (<1.52 darbiet) fl-esponiment fil-plażma (AUC) u fisCmax tal-metabolit attiv tiegħu telotristat meta mqabbla ma' individwi f'saħħithom għal b'indeboliment ħafif.
English: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n° 16A-1°B
Maltese: Alameda Fernão Lopes, n° 16A-1°B 1495 - 190
English: Other transporters Based on in vitro findings, no clinically-relevant interaction is expected with other transporters.
Maltese: Ibbażat fuq riżultati in vitro, l-ebda interazzjoni klinikament rilevanti mhi mistennija ma' trasportaturi oħrajn.
English: Overall, 18 patients (13.2%) prematurely discontinued from the study during the DBT Period, 7 patients in the placebo group, 3 in the telotristat ethyl 250 mg group and 8 in the higher dose group.
Maltese: B'mod globali, 18-il pazjent (13.2%) ma komplewx l-istudju qabel iż-żmien matul il-Perjodu DBT, 7 pazjenti fil-grupp tal-plaċebo, 3 fil-grupp ta' telotristat ethyl 250 mg, u 8 fil-grupp ta' doża ogħla.
English: Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome.
Maltese: Permezz ta' inibizzjoni ta' TPH1 periferali, telotristat inaqqas il-produzzjoni ta' serotonin, u b'hekk itaffi s-sintomi assoċjati mas-sindrome karċinojde.
English: In an in vivo clinical drug-drug interaction (DDI) study with midazolam (a sensitive CYP3A4 substrate), following administration of multiple doses of telotristat ethyl, the systemic exposure to concomitant midazolam was significantly decreased (see section 4.5).
Maltese: Fi studju kliniku in vivo dwar interazzjoni bejn mediċina u oħra (DDI, drug-drug interaction) b'midazolam (sottostrat sensittiv ta' CYP3A4), wara l-għoti ta' dożi multipli ta' telotristat ethyl, lesponiment sistemiku għal midazolam konkomitanti tnaqqas b'mod sinifikanti (ara sezzjoni 4.5) .
English: The study included a 12-week double-blind treatment (DBT) period, in which patients initially received placebo (n=45), telotristat ethyl 250 mg (n=45) or a higher dose (telotristat ethyl 500 mg; n=45) tid.
Maltese: L-istudju inkluda perjodu ta' kura double-blind (DBT) ta' 12-il ġimgħa, li fih il-pazjenti inizjalment rċevew plaċebo (n=45), telotristat ethyl 250 mg (n=45) jew doża ogħla (telotristat ethyl 500 mg; n=45) tid.
English: The apparent half-life of telotristat ethyl in normal healthy volunteers following a single 500 mg oral dose 14C-telotristat ethyl was approximately 0.6 hour and that of its active metabolite was 5 hours.
Maltese: Il-half-life apparenti ta' telotristat ethyl f'voluntiera normali b'saħħithom wara doża orali waħda ta' 500 mg 14C-telotristat ethyl kienet madwar 0.6 ta' siegħa, u dik tal-metabolit attiv tiegħu kienet ta' 5 sigħat.
English: This includes:
Maltese: Tel.:
English: Based on post marketing and clinical data it is recommended to update section 4.8 to include nausea as an adverse drug reaction in Section 4.8 under the SOC Gastrointestinal disorders with a frequency “very common”.
Maltese: Abbażi tad-data klinika u ta' wara t-tqegħid fis-suq, huwa rakkomandat li tiġi aġġornata s-sezzjoni 4.8 biex tinkludi tqalligħ bħala reazzjoni avversa għall-mediċina fis-Sezzjoni 4.8 taħt is-SOC Disturbi gastrointestinali bi frekwenza “komuni ħafna”.
English: In a 39-week repeat-dose toxicity study in dogs NOAEL of 300 mg/kg/day was determined.
Maltese: Fi studju ta' 39 ġimgħa dwar tossiċità minn dożi ripetuti fil-klieb, ġie stabbilit NOAEL ta' 300 mg/kg/jum.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew assorbiment ħażin tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Although patients with carcinoid syndrome may have a predisposition for depression, there were 38 post-marketing cases indicative of depression and depression-related events including two cases with positive dechallenge.
Maltese: Għalkemm pazjenti b'sindrome karċinojde jista' jkollhom predispożizzjoni għal depressjoni, kien hemm 38 każ ta' wara t-tqegħid fissuq li jindikaw depressjoni u avvenimenti relatati ma' depressjoni inklużi żewġ każijiet b'dechallenge pożittiva.
English: The influence of age on the pharmacokinetics of telotristat ethyl and its active metabolite has not been conclusively evaluated.
Maltese: L-influwenza tal-età fuq il-farmakokinetika ta' telotristat ethyl u l-metabolit attiv tiegħu, ma ġietx evalwata b'mod konklużiv.
English: • Fever
Maltese: • Gass
English: • medicines used to avoid transplant rejection, such as cyclosporine.
Maltese: • mediċini li jintużaw biex jiġi evitat rifjut ta' trapjant, bħal cyclosporine.
English: The renal clearance of telotristat was 0.126 L/h.
Maltese: Ittneħħija mill-kliewi ta' telotristat kienet ta' 0.126
English: At doses of 200 and 500 mg/kg/day degeneration/necrosis in the nonglandular and/or glandular portions of the stomach and/or increased protein droplets in the glandular portions were observed.
Maltese: F'dożi ta' 200 u 500 mg/kg/jum, ġew osservati deġenerazzjoni/nekrożi filporzjonijiet mhux glandolari u/jew glandolari tal-istonku, u/jew żieda fil-qtar tal-proteini filporzjonijiet glandolari.
English: Other CYPs Based on in vitro findings, no clinically-relevant interaction is expected with other cytochromes P450.
Maltese: Ibbażat fuq riżultati in vitro, l-ebda interazzjoni klinikament rilevanti mhi mistennija ma' ċitokromi P450 oħrajn.
English: Both the prodrug (telotristat ethyl) and its active metabolite (telotristat) are inhibitors of L-tryptophan hydroxylases (TPH1 and TPH2, the rate limiting steps in serotonin biosynthesis).
Maltese: Kemm il-promediċina (telotristat ethyl) kif ukoll il-metabolit attiv tagħha (telotristat) huma inibituri ta' L-tryptophan hydroxylases (TPH1 u TPH2, passi li jillimitaw ir-rata fil-bijosintesi ta' serotonin).
English: Abdominal distension was reported in 7.1% of patients (5/70) receiving telotristat ethyl 250 mg tid, versus 4.2% in the placebo group (3/71).
Maltese: Nefħa addominali ġiet irrappurtata f'7.1% tal-pazjenti (5/70) li kienu qed jirċievu telotristat ethyl 250 mg tid, kontra 4.2% fil-grupp tal-plaċebo (3/71).
English: A post-hoc analysis showed that the average number of daily short-acting SSA injections used for rescue therapy over the 12-week DBT period was 0.3 and 0.7 in the telotristat ethyl 250 mg and placebo groups, respectively.
Maltese: Analiżi post-hoc uriet li n-numru medju ta' injezzjonijiet ta' kuljum b'SSA li jaġixxu għal żmien qasir li ntużaw għal terapija ta' salvataġġ fuq il-perjodu DBT ta' 12-il ġimgħa, kien ta' 0.3 u 0.7 fil-gruppi ta' telotristat ethyl 250 mg u tal-plaċebo, rispettivament.
English: Xermelo should be taken with food (see sections 5.1 and 5.2).
Maltese: Xermelo għandu jittieħed mal-ikel (ara sezzjonijiet 5.1 u 5.2).
English: When the full effect of telotristat is observed (during the last 6 weeks of the DBT period) the proportion of responders with at least 30% BM reduction was 51% (23/45) in the 250 mg group versus 22% (10/45) in the placebo group (post-hoc analysis).
Maltese: Meta l-effett sħiħ ta' telotristat ġie osservat (matul l-aħħar 6 ġimgħat tal-perjodu DBT), il-proporzjon ta' dawk li kellhom rispons bi tnaqqis ta' mill-inqas 30% fil-BM kien ta' 51% (23/45) fil-grupp ta' 250 mg, kontra 22% (10/45) fil-grupp tal-plaċebo (analiżi post-hoc).
English: Each tablet is approximately 17 mm long by 7.5 mm wide with ‘T-E' debossed on one side and ‘250' debossed on the other.
Maltese: Kull pillola hija madwar 17 mm twila u 7.5 mm wiesa', b'‘T-E' imnaqqxa fuq naħa waħda u ‘250' imnaqqxa fuq innaħa l-oħra.
English: Number of patients Change averaged over 12 weeks: mean (SD)
Maltese: Numru ta' Pazjenti Bidla Perċentwali f'Ġimgħa 12: Medja (SD)
English: These have not been associated with concomitant elevations in total serum bilirubin.
Maltese: Dawn ma ġewx assoċjati ma' żidiet fl-istess ħin fil-bilirubina totali fis-serum.
English: Overall, severe to moderate renal impairment did not result in a clinically meaningful change in the PK profile or safety of telotristat ethyl and its metabolite telotristat.
Maltese: B'mod globali, indeboliment sever għal moderat tal-kliewi ma rriżultax f'bidla klinikament sinifikanti fil-profil tal-PK jew fis-sigurtà ta' telotristat ethyl u l-metabolit tiegħu telotristat.
English: Elevations in hepatic enzymes were observed in clinical studies (see section 4.8).
Maltese: Żidiet fl-enzimi tal-fwied ġew osservati fl-istudji kliniċi (ara sezzjoni 4.8).
English: Each film-coated tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl.
Maltese: Kull pillola fiha telotristat etiprate, ekwivalenti għal 250 mg ta' telotristat ethyl.
English: The mean u5-HIAA excretion at baseline was 69.1 mg/24hours in the 250 mg group (n=17) and
Maltese: Il-medja ta' tneħħija ta' u5-HIAA fil-linja bażi kienet ta' 69.1 mg/24 siegħa fil-grupp ta' 250 mg (n=17) u 84.
English: Tablet core
Maltese: BM kuljum.
English: Peak plasma levels of telotristat ethyl were achieved in 0.53 to 2.00 hours and those of the active metabolite in 1.50 to 3.00 hours after oral administration.
Maltese: Il-livelli massimi fil-plażma ta' telotristat ethyl intlaħqu f'0.53 ta' siegħa sa sagħtejn, u dawk tal-metabolit attiv f'1.50 sa 3.00 sigħat wara l-għoti orali.
English: Finally, it is recommended to add depression and depressed mood to section 4.8 of the SmPC and section 4 of PL under Psychiatric disorders with frequency “common”.
Maltese: Finalment, huwa rakkomandat li jiżdiedu depressjoni u burdata depressa fis-sezzjoni 4.8 tal-SmPC u ssezzjoni 4 tal-PL taħt Disturbi psikjatriċi bi frekwenza “komuni”.
English: The long-term safety and tolerability of telotristat was evaluated in a nonpivotal (nonrandomized), phase 3, multicentre, open-label, long-term extension study.
Maltese: Is-sigurtà u t-tollerabbiltà fit-tul ta' telotristat ġew evalwati fi studju ta' estensjoni fit-tul mhux pivitali (li fih il-parteċipanti ma ntgħażlux b'mod każwali), ta' fażi 3, multiċentriku u open-label.
English: Telotristat ethyl and its active metabolite were not shown to be inducers of CYP3A4 at systemically relevant concentrations, based on in vitro findings.
Maltese: Ma ntweriex li telotristat ethyl u l-metabolit attiv tiegħu huma indutturi ta' CYP3A4 f'konċentrazzjonijiet sistemikament rilevanti, ibbażat fuq riżultati in vitro.
English: No decrease in brain 5-HT and 5-HIAA levels were observed after intravenous application of active metabolite.
Maltese: Ma ġie osservat l-ebda tnaqqis f'5-HT fil-moħħ, u livelli ta' 5-HIAA ġew osservati wara l-applikazzjoni ġolvini tal-metabolit attiv.
English: a. Analysis of covariance including treatment group and urinary 5-HIAA stratification at randomisation as fixed effects, and the baseline number of BM as a fixed covariate.
Maltese: Analiżi ta' kovarjanza li tinkludi grupp ta' kura u stratifikazzjoni 5-HIAA urinarja fl-għażla b'mod każwali bħala effetti fissi, u n-numru fil-linja bażi ta' BM bħala kovarjat fiss.
English: Statistically significant reductions in u5-HIAA were seen for telotristat ethyl 250 mg tid compared with placebo in both Phase 3 studies.
Maltese: Tnaqqis statistikament sinifikanti f'u5-HIAA ġie osservat għal telotristat ethyl 250 mg tid mqabbel mal-plaċebo fiż-żewġ studji ta' Fażi 3.
English: Eight subjects with severe to moderate renal impairment not requiring dialysis [eGFR ≤ 33 mL/min at screening and ≤40 mL/min at the day prior to dosing] and eight healthy to mildly impaired subjects [eGFR ≥88 mL/min at screening and ≥83 mL/min at the day prior to dosing] were included in this study.
Maltese: Tmien individwi b'indeboliment sever għal moderat tal-kliewi li ma kinux jeħtieġu dijalisi [eGFR ≤33 mL/min fl-iskrinjar u ≤40 mL/min fil-jum qabel id-dożaġġ] u tmien individwi f'saħħithom għal b'indeboliment ħafif [eGFR ≥88 mL/min fl-iskrinjar u ≥83 mL/min fil-jum qabel id-dożaġġ] kienu inklużi f'dan l-istudju.
English: Concomitant administration of short-acting octreotide with Xermelo significantly decreased the systemic exposure of telotristat ethyl and telotristat, the active metabolite (see section 5.2).
Maltese: L-għoti fl-istess ħin ta' octreotide li jaġixxi għal żmien qasir ma' Xermelo, naqqas b'mod sinifikanti lesponiment sistemiku ta' telotristat ethyl u telotristat, il-metabolit attiv (ara sezzjoni 5.2).
English: • medicines used to treat epilepsy, such as valproic acid.
Maltese: • mediċini li jintużaw għall-kura tal-epilessija, bħal valproic acid.
English: Following administration of a single 500 mg dose of telotristat ethyl (twice the recommended dosage) under fasted conditions in healthy subjects, the mean Cmax and AUC0-inf were 4.4 ng/mL and 6.23 ng•hr/mL, respectively for telotristat ethyl.
Maltese: Wara l-għoti ta' doża waħda ta' 500 mg ta' telotristat ethyl (id-doppju tad-dożaġġ rakkomandat) taħt kundizzjonijiet sajmin f'individwi b'saħħithom, il-medja tas-Cmax u l-AUC0-inf kienu 4.4 ng/mL u 6.23 ng•hr/mL, rispettivament għal telotristat ethyl.
English: Via del Bosco Rinnovato n. 6 Milanofiori Nord Palazzo U7 20090 Assago (MI) Tel: + 39 - 02 - 39 22 41
Maltese: 6 Milanofiori Nord Palazzo U7 20090
English: A total of 135 patients were evaluated for efficacy.
Maltese: Total ta' 135 pazjent ġew evalwati għall-effikaċja.
English: Following a single oral 250 mg dose of telotristat ethyl to heathy volunteers, urine concentrations of telotristat ethyl were close to or below the limit of quantification (<0.1 ng/mL).
Maltese: Wara doża orali waħda ta' 250 mg ta' telotristat ethyl lil voluntiera f'saħħithom, il-konċentrazzjonijiet ta' telotristat ethyl fl-awrina kienu viċin jew taħt il-limitu ta' kwantifikazzjoni (<0.1 ng/mL).
English: All patients had well-differentiated metastatic neuroendocrine tumour with carcinoid syndrome.
Maltese: Il-pazjenti kollha kellhom tumuri newroendokrinali metastatiċi ddifferenzjati sew u sindrome karċinojde.
English: The maximum dose of Xermelo is 750 mg in 24 hours.
Maltese: Id-doża massima ta' Xermelo hija ta' 750 mg f'24 siegħa.