FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you take Xermelo 3.
Croatian: Što morate znati prije nego počnete uzimati Xermelo
English: Ipsen Farmaceutica B.V. Taurusavenue 33b 2132 LS Hoofddorp Tel: + 31 (0) 23 554 1600
Croatian: Taurusavenue 33b 2132 LS Hoofddorp Tel: + 31 (0) 23 554 1600
English: In a 39-week repeat-dose toxicity study in dogs NOAEL of 300 mg/kg/day was determined.
Croatian: U 39-tjednom ispitivanju toksičnosti ponovljene doze u pasa određena je razina NOAEL-a od 300 mg/kg na dan.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness
Croatian: Unutar svake skupine nuspojave su prikazane slijedom prema manjoj ozbiljnosti.
English: Patients having participated in any Xermelo phase 2 or phase 3 carcinoid syndrome study were eligible to enter the study at the same dose level and regimen as identified in their original study, for at least 84 weeks of treatment.
Croatian: Bolesnici koji su sudjelovali bilo u fazi 2 bilo u fazi 3 ispitivanja karcinoidnog sindroma sa Xermelom bili su pogodni za ulazak u ispitivanje, pri istoj dozi i režimu doziranja kao u izvornom ispitivanju, za liječenje u trajanju od najmanje 84 tjedna.
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).
Croatian: Nakon jednokratne peroralne doze od 250 mg etiltelotristata u zdravih dobrovoljaca, koncentracije etiltelotristata u urinu bile su blizu ili ispod granice određivanja (< 0,1 ng/ml).
English: Statistically significant reductions in u5-HIAA were seen for telotristat ethyl 250 mg tid compared with placebo in both Phase 3 studies.
Croatian: Statistički značajno smanjenje razine u5-HIAA opaženo je za etiltelotristat u dozi od 250 mg TID u usporedbi s placebom u oba ispitivanja faze 3.
English: Variability of the main plasma telotristat PK parameters was higher in subjects with severe to moderate renal impairment, with CV% ranging from 53.3% for Cmax to 77.3% for AUC as compared to 45.4% for Cmax and 39.7% for AUC in healthy to mildly impaired subjects, respectively.
Croatian: Varijabilnost glavnih farmakokinetičkih parametara LP-778902 u plazmi bila je veća u ispitanika s teškim do umjerenim oštećenjem funkcije bubrega, s CV% u rasponu od 53,3% za Cmax do 77,3% za AUC u usporedbi s 45,4% za Cmax i 39,7% za AUC u zdravih ispitanika ili onih s blagim oštećenjem.
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).
Croatian: Prolijek (etiltelotristat) kao i njegov aktivni metabolit (telotristat) inhibitori su L-triptofan hidroksilaza (TPH1 i TPH2, koraka koji ograničavaju brzinu biosinteze serotonina).
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.
Croatian: Vršne razine etiltelotristata u plazmi dosegnute su između 0,53 i 2,00 sata, a one aktivnog metabolita između 1,50 i 3,00 sata nakon peroralne primjene.
English: The microscopic changes in the gastrointestinal tract reversed with a 4-week recovery period.
Croatian: Mikroskopske promjene u probavnom sustavu vratile su se u normalno stanje nakon razdoblja oporavka od 4 tjedna.
English: The proportions of patients who were “very satisfied” were 0/9 (0%) on placebo, 5/9 (56%) on telotristat ethyl 250 mg tid and 7/15 (47%) on a higher dose of telotristat ethyl.
Croatian: Udjeli bolesnika koji su bili „vrlo zadovoljni“ bili su 0/9 (0%) za placebo, 5/9 (56%) za etiltelotristat 250 mg TID i 7/15 (47%) za višu dozu etiltelotristata.
English: Constipation was reported in patients using a higher dose (500 mg).
Croatian: Konstipacija je zabilježena u bolesnika koji su uzimali više doze (500 mg).
English: • medicines used to treat epilepsy, such as valproic acid.
Croatian: • lijekove kojima se liječi epilepsija, kao što je valproatna kiselina
English: Table 2: BM response (TELESTAR Study) Parameter
Croatian: Tablica 2: Broj pražnjenja crijeva kao odgovor (ispitivanje TELESTAR)
English: White to off-white film-coated oval tablets (approximately 17 mm long by 7.5 mm wide) with ‘T-E' debossed on one side and ‘250' debossed on the other side.
Croatian: Bijele do bjelkaste filmom obložene ovalne tablete (duljine približno 17 mm i širine 7,5 mm) s oznakom „T-E” utisnutom na jednoj strani i „250” na drugoj strani.
English: Brain 5-HIAA levels were unchanged at all doses of telotristat ethyl examined.
Croatian: Razine 5-HIAA u mozgu bile su nepromijenjene kod svih ispitivanih doza etiltelotristata.
English: Gastrointestinal disorders including nausea, diarrhoea, abdominal pain and vomiting have been reported in healthy subjects taking a single dose of 1,500 mg in a phase 1 study.
Croatian: Poremećaji probavnog sustava uključujući mučninu, proljev, bol u abdomenu i povraćanje zabilježeni su u ispitivanju faze I u zdravih ispitanika koji su uzeli jednu dozu od 1500 mg.
English: Questions were asked to blinded participants to further characterise the degree of change experienced during the trial.
Croatian: Bolesnicima koji nisu znali koju su terapiju primali postavljana su pitanja kako bi se dodatno opisale značajke stupnja promjene koje su opazili tijekom ispitivanja.
English: Therefore, dose adjustment does not appear necessary in patients with mild, moderate or severe renal impairment; who are not requiring dialysis.
Croatian: Stoga prilagodba doze nije potrebna u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega; koji ne zahtijevaju dijalizu.
English: All patients had well-differentiated metastatic neuroendocrine tumour with carcinoid syndrome.
Croatian: Svi bolesnici imali su dobro diferencirani metastatski neuroendokrini tumor s karcinoidnim sindromom.
English: If you stop taking Xermelo
Croatian: Ako prestanete uzimati Xermelo
English: Your doctor may need to change the dose of your medicines.
Croatian: U tom Vam slučaju liječnik možda treba promijeniti dozu lijekova koje uzimate.
English: Posology The recommended dose is 250 mg three times daily (tid).
Croatian: Doziranje Preporučena doza je 250 mg tri puta na dan (TID).
English: Based on the high inter-subject variability observed, accumulation in a subset of patients with carcinoid syndrome cannot be excluded.
Croatian: Na temelju visoke varijabilnosti opažene između bolesnika, ne može se isključiti akumulacija u podskupini bolesnika s karcinoidnim sindromom.
English: If you forget to take Xermelo
Croatian: Ako ste zaboravili uzeti Xermelo
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.
Croatian: Analiza kovarijance uključujući liječenu skupinu i stratifikaciju prema razini 5-HIAA u mokraći kao fiksne učinke i broj pražnjenja crijeva na početku kao fiksnu kovarijatu na randomizaciji.
English: In patients with hepatic impairment, continuous monitoring for adverse events and worsening of liver function is recommended.
Croatian: U bolesnika s oštećenjem funkcije jetre preporučuje se kontinuirano praćenje zbog moguće pojave štetnih događaja i pogoršanja funkcije jetre.
English: Percent change from baseline in u5-HIAA excretion (mg/24 hours) at week 12
Croatian: Postotak promjene od početne vrijednosti u izlučivanju u5-HIAA (mg/24 sata) u 12. tjednu
English: Ipsen Ltd.
Croatian: United Kingdom Ipsen Ltd.
English: Administration of a single dose of 250 mg was well tolerated in subjects with severe to moderate renal impairment.
Croatian: Primjena jedne doze od 250 mg dobro je podnošena u ispitanika s teškim do umjerenim oštećenjem funkcije bubrega.
English: A study was conducted to investigate the impact of renal impairment on the pharmacokinetics of a single dose of telotristat ethyl 250 mg.
Croatian: Provedeno je ispitivanje kako bi se ispitao utjecaj oštećenja funkcije bubrega na farmakokinetiku jedne doze etiltelotristata od 250 mg.
English: Pharmaswiss d.o.o.
Croatian: Pharmaswiss d.o.o. Brodišče 32
English: After oral administration, telotristat ethyl undergoes hydrolysis via carboxylesterases to its active and major metabolite.
Croatian: Nakon peroralne primjene, etiltelotristat se karboksilesterazom hidrolizira u svoj aktivni i glavni metabolit.
English: Other transporters Based on in vitro findings, no clinically-relevant interaction is expected with other transporters.
Croatian: Na temelju in vitro podataka ne očekuju se klinički značajne interakcije s drugim prijenosnicima.
English: 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).
Croatian: 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).
English: 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.
Croatian: U bolesnika s umjerenim oštećenjem funkcije jetre (Child Pugh stadij B), može biti potrebno smanjiti dozu na 250 mg jednom dnevno ovisno o podnošljivosti.
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.
Croatian: Istodobna primjena lijeka Xermelo može smanjiti djelotvornost lijekova koji su supstrati CYP2B6 (npr. valproatna kiselina, bupropion, sertralin) smanjivanjem sistemske izloženosti ovim lijekovima.
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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Telotristat ethyl inhibited MRP2-mediated transport (98% inhibition).
Croatian: Etiltelotristat inhibirao je prijenos posredovan proteinom MRP2 (inhibicija od 98%).
English: Elevations in hepatic enzymes were observed in clinical studies (see section 4.8).
Croatian: U kliničkim ispitivanjima opažena su povišenja jetrenih enzima (vidjeti dio 4.8).
English: If you need treatment with octreotide subcutaneous injections, you should have your injection at least 30 minutes after taking Xermelo.
Croatian: • oktreotid; ako Vam je potrebno liječenje potkožnim injekcijama oktreotida, te injekcije trebate primati nakon što je prošlo barem 30 minuta od uzimanja lijeka Xermelo.
English: • medicines used to lower cholesterol levels, such as simvastatin.
Croatian: • lijekove koji snižavaju razine kolesterola, kao što je simvastatin
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).
Croatian: 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).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products: Various alimentary tract and metabolism products, ATC code: A16AX15
Croatian: Razni lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AX15
English: Table 3: u5-HIAA excretion at baseline and week 12 (TELESTAR Study) Parameter
Croatian: Tablica 3: Izlučivanje u5-HIAA na početku i u 12. tjednu (ispitivanje TELESTAR)
English: c Faecaloma has only been observed in a clinical study at a dosage of 500mg tid (twice the recommended dose).
Croatian: Fekalom je uočen samo u kliničkoj studiji u dozi od 500 mg tri puta dnevno (dvostruka preporučena doza).
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Women should use effective methods of contraception while taking this medicine.
Croatian: Dok uzimaju ovaj lijek, žene trebaju primjenjivati učinkovite metode kontracepcije.
English: 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).
Croatian: 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).
English: Polyvinyl alcohol (partially hydrolysed) (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521)
Croatian: titanijev dioksid (E171) makrogol 3350 (E1521) talk (E553b)
English: Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes tested and telotristat should be discontinued if liver injury is suspected.
Croatian: 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.
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).
Croatian: 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).
English: 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.
Croatian: 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.
English: The use of telotristat is not recommended in patients with severe hepatic impairment as no data are available.
Croatian: Primjena telotristata ne preporučuje se u bolesnika s teškim oštećenjem funkcije jetre jer nema dostupnih podataka.
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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Brodišče 32
Croatian: Färögatan 33
English: • feeling or being sick, abnormally dark urine, yellow skin or eyes, pain in the upper right belly.
Croatian: • mučnina ili povraćanje, neuobičajeno tamna mokraća, žuta boja kože ili bjeloočnica, bol u gornjem desnom dijelu trbuha.
English: There was no significant difference between treatment groups for the endpoints of flushing and abdominal pain.
Croatian: Nije bilo značajne razlike između liječenih skupina u navali crvenila i bola u abdomenu kao mjerama ishoda.
English: • Feeling tired or weak (fatigue)
Croatian: • osjećaj umora ili slabosti • mučnina
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).
Croatian: Istodobna primjena kratkodjelujućeg oktreotida i lijeka Xermelo značajno je smanjila sistemsku izloženost etiltelotristatu i aktivnom metabolitu telotristatu (vidjeti dio 5.2).
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).
Croatian: 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).
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Croatian: Obratite se liječniku, ljekarniku ili medicinskoj sestri ako opazite bilo koju od sljedećih nuspojava:
English: Telotristat has minor influence on the ability to drive and use machines.
Croatian: Telotristat malo utječe na upravljanje vozilima i rad strojevima.
English: Systemic exposure to LP-951757 was about 35% of the systemic exposure to telotristat (active metabolite) in the mass balance study.
Croatian: U ispitivanju masene bilance, na sistemsku izloženost metabolitu LP-951757 odnosilo se oko 35% sistemske izloženosti telotristatu (aktivni metabolit).
English: Elderly patients (65 years of age and above) No specific dose recommendations are available for elderly patients (see section 5.2).
Croatian: Za bolesnike starije dobi nema posebnih preporuka doze (vidjeti dio 5.2).
English: Alanine aminotransferase increased (ALT), Aspartate aminotransferase increased (AST),
Croatian: povišena aspartat aminotransferaza (AST), povišena alkalna fosfataza (ALP)
English: Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Croatian: Obratite se liječniku, ljekarniku ili medicinskoj sestri ako opazite bilo koju od prethodno navedenih nuspojava.
English: The primary endpoint was the percent change from Baseline in u5-HIAA at Week 12.
Croatian: Primarni je ishod bio postotak promjene razine u5-HIAA u 12. tjednu u odnosu na početnu vrijednost.
English: Lactose anhydrous Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Silica, colloidal anydrous
Croatian: Jezgra tablete laktoza, bezvodna hidroksipropilceluloza karmelozanatrij, umrežena magnezijev stearat silicijev dioksid, koloidni, bezvodni
English: 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.
Croatian: 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.
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.
Croatian: 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.
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).
Croatian: Loperamid (inhibitor CES2) imao je in vitro umjereni učinak na metabolizam etiltelotristata smanjujući nastanak telotristata za < 30% (vidjeti dio 4.5).
English: Ipsen Pharma SAS Lietuvos filialas T. Narbuto g. 5,
Croatian: Ipsen Pharma SAS Lietuvos filialas T.
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%).
Croatian: 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%).
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%).
Croatian: 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%).
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.
Croatian: 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.
English: Xermelo 250 mg film-coated tablets telotristat ethyl
Croatian: Xermelo 250 mg filmom obložene tablete etiltelotristat
English: Short acting octreotide
Croatian: Kratkodjelujući oktreotid