natgillin/translations-raw huggingface dataset:
A study was conducted to investigate the impact of renal impairment on the pharmacokinetics of a single dose of telotristat ethyl 250 mg. 
Provedeno je ispitivanje kako bi se ispitao utjecaj oštećenja funkcije bubrega na farmakokinetiku jedne doze etiltelotristata od 250 mg.
Pharmaswiss d.o.o. 
Pharmaswiss d.o.o. Brodišče 32
After oral administration, telotristat ethyl undergoes hydrolysis via carboxylesterases to its active and major metabolite. 
Nakon peroralne primjene, etiltelotristat se karboksilesterazom hidrolizira u svoj aktivni i glavni metabolit.
Other transporters Based on in vitro findings, no clinically-relevant interaction is expected with other transporters. 
Na temelju in vitro podataka ne očekuju se klinički značajne interakcije s drugim prijenosnicima.
Concomitant use of Xermelo may decrease the efficacy of medicinal products that are CYP3A4 substrates (e.g. midazolam, everolimus, sunitinib, simvastatin, ethinyloestradiol, amlodipine, cyclosporine…) by decreasing their systemic exposure (see section 5.2). 
Istodobna primjena lijeka Xermelo može smanjiti djelotvornost lijekova koji su supstrati CYP3A4 (npr. midazolam, everolimus, sunitinib, simvastatin, etinilestradiol, amlodipin, ciklosporin…) smanjivanjem sistemske izloženosti ovim lijekovima (vidjeti dio 5.2).
In patients with moderate hepatic impairment (Child Pugh score B), it may be necessary to reduce the dose to 250 mg once daily according to tolerability. 
U bolesnika s umjerenim oštećenjem funkcije jetre (Child Pugh stadij B), može biti potrebno smanjiti dozu na 250 mg jednom dnevno ovisno o podnošljivosti.
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. 
Istodobna primjena lijeka Xermelo može smanjiti djelotvornost lijekova koji su supstrati CYP2B6 (npr. valproatna kiselina, bupropion, sertralin) smanjivanjem sistemske izloženosti ovim lijekovima.
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. 
Ispitivanje je uključivalo 12-tjedno razdoblje dvostruko slijepog liječenja u kojemu su bolesnici na početku primali placebo (n = 45), etiltelotristat u dozi od 250 mg (n = 45) ili višu dozu (etiltelotristat 500 mg; n = 45) TID.
During the study, patients were allowed to use rescue medication (short-acting SSA therapy) and anti-diarrhoeals for symptomatic relief but were required to be on stable-dose long-acting SSA therapy for the duration of the DBT period. 
Bolesnicima su tijekom ispitivanja bili dopušteni simptomatski lijekovi (terapija kratkodjelujućim SSA-om) i lijekovi protiv proljeva za olakšavanje simptoma, ali su za trajanja razdoblja dvostruko slijepog liječenja morali biti na stabilnoj dozi terapije dugodjelujućim SSA-om.
Telotristat ethyl inhibited MRP2-mediated transport (98% inhibition). 
Etiltelotristat inhibirao je prijenos posredovan proteinom MRP2 (inhibicija od 98%).
Elevations in hepatic enzymes were observed in clinical studies (see section 4.8). 
U kliničkim ispitivanjima opažena su povišenja jetrenih enzima (vidjeti dio 4.8).
If you need treatment with octreotide subcutaneous injections, you should have your injection at least 30 minutes after taking Xermelo. 
• oktreotid; ako Vam je potrebno liječenje potkožnim injekcijama oktreotida, te injekcije trebate primati nakon što je prošlo barem 30 minuta od uzimanja lijeka Xermelo.
• medicines used to lower cholesterol levels, such as simvastatin. 
• lijekove koji snižavaju razine kolesterola, kao što je simvastatin
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). 
Kada se promatra cjelokupni učinak telotristata (tijekom posljednjih 6 tjedana razdoblja dvostruko slijepog liječenja), udio bolesnika s odgovorom od najmanje 30% smanjenja u broju pražnjenja crijeva bio je 51% (23/45) u skupini koja primala 250 mg naspram 22% (10/45) u skupini koja primala placebo (post hoc analiza).
Pharmacotherapeutic group: Other alimentary tract and metabolism products: Various alimentary tract and metabolism products, ATC code: A16AX15 
Razni lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AX15
Table 3: u5-HIAA excretion at baseline and week 12 (TELESTAR Study) Parameter 
Tablica 3: Izlučivanje u5-HIAA na početku i u 12. tjednu (ispitivanje TELESTAR)
c Faecaloma has only been observed in a clinical study at a dosage of 500mg tid (twice the recommended dose). 
Fekalom je uočen samo u kliničkoj studiji u dozi od 500 mg tri puta dnevno (dvostruka preporučena doza).
Concomitant use of telotristat etiprate (Xermelo, the hippurate salt of telotristat ethyl) with acidreducers (omeprazole and famotidine) showed that the AUC of telotristat ethyl was increased 2-3 fold, while the AUC of the active metabolite (telotristat) was not changed. 
Istodobna primjena telotristatetiprata (Xermelo, hipuratna sol etiltelotristata) i lijekova koji smanjuju želučanu kiselinu (omeprazol i famotidin) pokazala je da je AUC etiltelotristata bio povećan 2 do 3 puta, dok AUC aktivnog metabolita (telotristat) nije bio promijenjen.
A study examining the effect of short-acting octreotide (3 doses of 200◦micrograms given 8◦hours apart) on the single dose pharmacokinetics of Xermelo in normal healthy volunteers showed an 83% and 81% decrease in Cmax and AUC of telotristat ethyl and telotristat, respectively (see section 4.5). 
Ispitivanje u kojem se u zdravih dobrovoljaca ispitivao učinak kratkodjelujućeg oktreotida (3 doze od 200 mikrograma davane u razmacima od 8 sati) na farmakokinetiku jedne doze lijeka Xermelo pokazalo je smanjenje od 83% i 81% u vrijednostima Cmax i AUC etiltelotristata odnosno telotristata (vidjeti dio 4.5).
Women should use effective methods of contraception while taking this medicine. 
Dok uzimaju ovaj lijek, žene trebaju primjenjivati učinkovite metode kontracepcije.
The most frequently reported adverse event in patients receiving telotristat ethyl 250 mg tid was abdominal pain (25.7%; 18/70) versus placebo (19.7%; 14/71). 
Najčešće prijavljen štetni događaj u bolesnika koji su primali etiltelotristat 250 mg TID bio je bol u abdomenu (25,7%; 18/70) u usporedbi s placebom (19,7%; 14/71).
Polyvinyl alcohol (partially hydrolysed) (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) 
titanijev dioksid (E171) makrogol 3350 (E1521) talk (E553b)
Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes tested and telotristat should be discontinued if liver injury is suspected. 
U bolesnika u kojih se jave simptomi koji ukazuju na disfunkciju jetre, potrebno je provesti pretragu jetrenih enzima i ako se sumnja na oštećenje jetre, prekinuti primjenu telotristata.
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). 
U ispitivanju učinka hrane, primjena etiltelotristata u dozi od 500 mg uz obrok s visokim udjelom masti rezultirala je višom izloženošću nepromijenjenom lijeku (vrijednosti Cmax, AUC0-tlast i AUC0-∞ više su 112%, 272% odnosno 264% u usporedbi s onima natašte) i njegovu aktivnom metabolitu (vrijednosti Cmax, AUC0-tlast i AUC0-∞ više su 47%, 32% odnosno 33% u usporedbi s onima natašte).
In patients with mild hepatic impairment (Child Pugh score A), it may be necessary to reduce the dose to 250 mg twice daily according to tolerability. 
U bolesnika s blagim oštećenjem funkcije jetre (Child Pugh stadij A) može biti potrebno smanjiti dozu na 250 mg dva puta dnevno ovisno o podnošljivosti.
The use of telotristat is not recommended in patients with severe hepatic impairment as no data are available. 
Primjena telotristata ne preporučuje se u bolesnika s teškim oštećenjem funkcije jetre jer nema dostupnih podataka.
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. 
U specifičnom kliničkom ispitivanju interakcije lijekova, Cmax i AUC feksofenadina (supstrat P-gp-a i MRP-2) povećao se za 16% kada je jedna doza feksofenadina od 180 mg bila peroralno primijenjena istodobno s dozom etiltelotristata od 500 mg TID (dva puta više od preporučene doze) tijekom 5 dana.
At the conclusion of the 12-week DBT period, 115 patients (85.2%) entered the 36-week open-label extension period, where all patients were titrated to receive a higher dose of telotristat ethyl (500 mg) tid. 
Kada je 12-tjedno razdoblje dvostruko slijepog liječenja zaključeno, 115 bolesnika (85,2%) uključeno je u 36-tjedno razdoblje otvorenog nastavka u kojemu su svi bolesnici titrirani na višu dozu etiltelotristata (500 mg) TID.
Brodišče 32 
Färögatan 33
• feeling or being sick, abnormally dark urine, yellow skin or eyes, pain in the upper right belly. 
• mučnina ili povraćanje, neuobičajeno tamna mokraća, žuta boja kože ili bjeloočnica, bol u gornjem desnom dijelu trbuha.
There was no significant difference between treatment groups for the endpoints of flushing and abdominal pain. 
Nije bilo značajne razlike između liječenih skupina u navali crvenila i bola u abdomenu kao mjerama ishoda.
• Feeling tired or weak (fatigue) 
• osjećaj umora ili slabosti • mučnina
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). 
Istodobna primjena kratkodjelujućeg oktreotida i lijeka Xermelo značajno je smanjila sistemsku izloženost etiltelotristatu i aktivnom metabolitu telotristatu (vidjeti dio 5.2).
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). 
U jednom in vivo ispitivanju kliničke interakcije lijekova s midazolamom (osjetljivim supstratom CYP3A4), nakon primjene višestrukih doza etiltelotristata sistemska izloženost istodobno primijenjenom midazolamu bila je značajno smanjena (vidjeti dio 4.5).
Tell your doctor, pharmacist or nurse if you notice any of the following side effects: 
Obratite se liječniku, ljekarniku ili medicinskoj sestri ako opazite bilo koju od sljedećih nuspojava:
Telotristat has minor influence on the ability to drive and use machines. 
Telotristat malo utječe na upravljanje vozilima i rad strojevima.
Systemic exposure to LP-951757 was about 35% of the systemic exposure to telotristat (active metabolite) in the mass balance study. 
U ispitivanju masene bilance, na sistemsku izloženost metabolitu LP-951757 odnosilo se oko 35% sistemske izloženosti telotristatu (aktivni metabolit).
Elderly patients (65 years of age and above) No specific dose recommendations are available for elderly patients (see section 5.2). 
Za bolesnike starije dobi nema posebnih preporuka doze (vidjeti dio 5.2).
Alanine aminotransferase increased (ALT), Aspartate aminotransferase increased (AST), 
povišena aspartat aminotransferaza (AST), povišena alkalna fosfataza (ALP)
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above. 
Obratite se liječniku, ljekarniku ili medicinskoj sestri ako opazite bilo koju od prethodno navedenih nuspojava.
The primary endpoint was the percent change from Baseline in u5-HIAA at Week 12. 
Primarni je ishod bio postotak promjene razine u5-HIAA u 12. tjednu u odnosu na početnu vrijednost.
Lactose anhydrous Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Silica, colloidal anydrous 
Jezgra tablete laktoza, bezvodna hidroksipropilceluloza karmelozanatrij, umrežena magnezijev stearat silicijev dioksid, koloidni, bezvodni
In Phase 1 studies, dosing with telotristat ethyl in healthy subjects (dose range: 100 mg once daily to 500 mg tid) produced statistically significant reductions from baseline in whole blood serotonin and 24-hour urinary 5-hydroxyindoleacetic acid (u5-HIAA) compared with placebo. 
U ispitivanjima faze 1 primjena etiltelotristata u zdravih ispitanika (raspon doze: od 100 mg jednom dnevno do 500 mg TID) dovela je, u usporedbi s placebom, do statistički značajnih smanjenja serotonina u punoj krvi i 5-hidroksiindoloctene kiseline (u5-HIAA) u 24-satnoj mokraći u odnosu na početne vrijednosti.
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. 
Nuspojave zabilježene u objedinjenim podacima o sigurnosti primjene u 70 bolesnika s karcinoidnim sindromom koji su u placebom kontroliranim kliničkim ispitivanjima primali etiltelotristrat u dozi od 250 mg TID u kombinaciji s terapijom SSA-om, navedene su u tablici 1.
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). 
Loperamid (inhibitor CES2) imao je in vitro umjereni učinak na metabolizam etiltelotristata smanjujući nastanak telotristata za < 30% (vidjeti dio 4.5).
Ipsen Pharma SAS Lietuvos filialas T. Narbuto g. 5, 
Ipsen Pharma SAS Lietuvos filialas T.
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%). 
U bolesnika liječenih dozom od 500 mg TID (dva puta više od preporučene doze), opažen je medijan omjera akumulacije na temelju AUC0-4h od 1,095 (minimum 0,274; maksimum 11,46; n = 16; 24. tjedan) s visokom varijabilnošću između ispitanika (%CV = 141,8%).
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%). 
U bolesnika liječenih dozom od 250 mg TID, opažena je blaga akumulacija razina telotristata s medijanom omjera akumulacije na temelju AUC0-4h od 1,55 [minimum 0,25; maksimum 5,00; n = 11; 12. tjedan], s visokom varijabilnošću između ispitanika (%CV = 72%).
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. 
Kada je nakon 5-dnevnog liječenja etiltelotristatom 500 mg TID (dva puta više od preporučene doze) istodobno peroralno primijenjeno 3 mg midazolama, srednja vrijednost Cmax midazolama smanjila se za 25%, a AUC0-inf za 48%, u usporedbi s primjenom samo midazolama.
Xermelo 250 mg film-coated tablets telotristat ethyl 
Xermelo 250 mg filmom obložene tablete etiltelotristat
Short acting octreotide 
Kratkodjelujući oktreotid
Tell your doctor immediately if you notice any of the following side effects: 
Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava:
In dogs decreases in brain 5-HT and 5-HIAA levels were observed at dose of 200 mg/kg/day and 30 mg/kg/day of telotristat etiprate per os, respectively. 
U pasa su smanjenja razina 5-HT i 5-HIAA u mozgu opažena pri peroralnoj dozi telotristatetiprata od 200 mg/kg na dan odnosno 30 mg/kg na dan.
PVC/PCTFE/PVC/Al blister The blisters are packaged in a carton. 
PVC/PCTFE/PVC/Al blister
Other CYPs Based on in vitro findings, no clinically-relevant interaction is expected with other cytochromes P450. 
Na temelju podataka dobivenih in vitro ne očekuju se klinički značajne interakcije s drugim enzimima citokroma P450.
If you feel tired, you should wait until you feel better before driving or using any tools or machines. 
Ako osjećate umor, trebate pričekati, a upravljati vozilima ili rukovati alatima ili strojevima možete tek kad se budete bolje osjećali.
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). 
b Povišena gama-glutamiltransferaza (uključujući preporučene pojmove povišena gamaglutamiltransferaza, gama-glutamiltransferaza i odstupanja u nalazima pretrage funkcije jetre / povišeni jetreni enzim, gdje je bila povišena gama-glutamiltransferaza).
Fatigue may occur following administration of telotristat (see section 4.8). 
Nakon primjene telotristata može se pojaviti umor (vidjeti dio 4.8).
• The active substance is telotristat ethyl. 
• Djelatna tvar je etiltelotristat.
How Xermelo works 
Kako Xermelo djeluje
Depression, depressed mood and decreased interest have been reported in clinical trials and from postmarketing in some patients treated with telotristat (see section 4.8). 
U kliničkim ispitivanjima i nakon stavljanja lijeka u promet u nekih su bolesnika liječenih telotristatom zabilježeni depresija, depresivno raspoloženje i smanjeni interes (vidjeti dio 4.8).
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. 
Kod ispitanika s teškim do umjerenim oštećenjem funkcije bubrega, uočeno je povećanje (1,3 puta) najveće izloženosti prema Cmax etiltelotristata i povećanje (< 1,52 puta) izloženosti u plazmi (AUC) i Cmax njegovom aktivnom metabolitu telotristatu, u usporedbi sa zdravim ispitanicima ili onima s blagim oštećenjem.
If you forget to take a dose, take your next dose when it is due, skipping the missed dose. 
Ako ste zaboravili uzeti dozu, preskočite tu propuštenu dozu i uzmite sljedeću prema svom uobičajenom rasporedu.
Elevations in ALT >3 × upper limit of normal (ULN) or ALP>2 ULN have been reported in patients receiving therapy with telotristat, most cases being reported at a higher dose (500 mg). 
U bolesnika koji su primali terapiju telotristatom zabilježene su povišene vrijednosti ALT > 3 × gornje granice normale (GGN) ili ALP > 2 GGN, s tim da je većina slučajeva bila zabilježena pri višim dozama (500 mg).
• Wind 
• vrućica
In rats decrease in brain serotonin (5-HT) was observed at doses≥1,000 mg/kg/day of telotristat etiprate per os. 
U štakora je opaženo smanjenje razine serotonina u mozgu (5-HT) kada je telotristatetiprat davan peroralno u dozama ≥ 1000 mg/kg na dan.
Shortacting octreotide should be administered at least 30 minutes after administration of Xermelo if treatment with short-acting octreotide is needed in combination with Xermelo. 
Ako je potrebno liječenje kratkodjelujućim oktreotidom u kombinaciji s lijekom Xermelo, kratkodjelujući oktreotid treba primijeniti nakon što je prošlo najmanje 30 minuta od primjene lijeka Xermelo.
Loperamide caused a <30% decrease in the formation of telotristat (active metabolite) in vitro (see section 5.2). 
Loperamid je in vitro prouzročio smanjenje stvaranja telotristata (aktivni metabolit) od < 30% (vidjeti dio 5.2).
They were on SSA therapy and had ≥4 daily BM. 
Liječeni su terapijom SSA-om, a broj pražnjenja crijeva iznosio im je ≥ 4 dnevno.
Telotristat ethyl 250 mg tid 
Etiltelotristat 250 mg TID
The percent change from baseline in u5-HIAA excretion at week 12 was +97.7% in the placebo group versus -33.2% in the 250 mg group. 
U odnosu na početnu vrijednost, postotak promjene u izlučivanju u5-HIAA bio je u 12. tjednu +97,7% u skupini koja je primala placebo naspram -33.2% u skupini koja je primala 250 mg etiltelotristata.
The efficacy and safety of telotristat for the treatment of carcinoid syndrome in patients with metastatic neuroendocrine tumours who were receiving SSA therapy was established in a 12-week double-blind, placebo-controlled, randomised, multicentre phase 3 trial in adult patients, which included a 36-week extension during which all patients were treated with open-label telotristat (TELESTAR Study). 
Djelotvornost i sigurnost telotristata u liječenju karcinoidnog sindroma u bolesnika s metastatskim neuroendokrinim tumorima koji su primali terapiju SSA-om ustanovljene su u 12-tjednom dvostruko slijepom, placebom kontroliranom, randomiziranom, multicentričnom ispitivanju faze 3 u odraslih bolesnika.
What Xermelo is used for 
Za što se Xermelo koristi
b. Defined as the proportion of responders with ≥30% reduction in daily number of BMs for ≥50% 
b. Definirano kao udio bolesnika s odgovorom u kojih se za ≥ 50% vremena tijekom razdoblja dvostruko slijepog liječenja broj pražnjenja crijeva na dan smanjio ≥ 30%. c. p = 0,01
In a hepatic impairment study conducted at a single dose of 500 mg, exposures to the parent compound and its active metabolite (based on AUC0-tlast) were higher in patients with mild hepatic impairment (2.3- and 2.4-fold, respectively) and in patients with moderate hepatic impairment (3.2and 3.5-fold, respectively) compared with healthy subjects. 
U ispitivanju oštećenja funkcije jetre provedenom primjenom jedne doze od 500 mg, izloženosti nepromijenjenom lijeku i njegovu aktivnom metabolitu (na temelju vrijednosti AUC0-tlast) bile su više u bolesnika s blagim oštećenjem funkcije jetre (2,3 odnosno 2,4 puta) i u bolesnika s umjerenim oštećenjem funkcije jetre (3,2 odnosno 3,5 puta) nego u zdravih ispitanika.
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. 
Prema post hoc analizi, prosječni broj injekcija kratkodjelujućeg SSA-a na dan primjenjivanih kao simptomatska terapija tijekom 12-tjednog razdoblja dvostruko slijepog liječenja, iznosio je 0,3 u skupini koja je primala etiltelotristat 250 mg i 0,7 u skupini koja je primala placebo.
Acid Reducers 
Lijekovi koji smanjuju želučanu kiselinu
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. 
Tijekom razdoblja dvostruko slijepog liječenja, ispitivanje je prijevremeno prekinulo ukupno 18 bolesnika (13,2%), od toga je 7 bolesnika bilo u skupini koja primala placebo, 3 u skupini koja je primala etiltelotristat 250 mg i 8 bolesnika u skupini koja je primala višu dozu.
How to take Xermelo 
Kako uzimati Xermelo
Telotristat ethyl and its active metabolite were not shown to be inducers of CYP3A4 at systemically relevant concentrations, based on in vitro findings. 
Na temelju podataka dobivenih in vitro pokazalo se da etiltelotristat i njegov aktivni metabolit nisu induktori CYP3A4 u sistemski relevantnim koncentracijama.
The influence of age on the pharmacokinetics of telotristat ethyl and its active metabolite has not been conclusively evaluated. 
Učinak dobi na farmakokinetiku etiltelotristata i njegova aktivnog metabolita nije procijenjen dovoljno za donošenje zaključka.
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. 
Nakon primjene jedne doze etiltelotristata od 500 mg (dva puta više od preporučene doze) natašte u zdravih ispitanika, srednje vrijednosti Cmax i AUC0-inf za etiltelotristat bile su 4,4 ng/ml odnosno 6,23 ng•h/ml., Srednje vrijednosti Cmax i AUC0-inf za telotristat bile su 610 ng/ml odnosno 2320 ng•h/ml.
D-81677 München Tel.: +49 89 262043289 
Tel.: +49 89 262043289