FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of Xermelo is not recommended in patients with end-stage renal disease requiring dialysis (eGFR < 15 mL/min requiring dialysis) because efficacy and safety of Xermelo in these patients has not been established.
Slovenian: Uporaba zdravila Xermelo ni priporočljiva pri bolnikih s končno odpovedjo ledvic, ki potrebujejo zdravljenje z dializo (ocenjena hitrost glomerulne filtracije [eGFR] < 15 ml/min, ki zahteva zdravljenje z dializo), saj učinkovitost in varnost zdravila Xermelo pri teh bolnikih nista bili dokazani.
English: Telotristat ethyl inhibited MRP2-mediated transport (98% inhibition).
Slovenian: Etiltelotristat je zaviral z MRP-2 posredovan prenos (98-% inhibicija).
English: If you forget to take a dose, take your next dose when it is due, skipping the missed dose.
Slovenian: Če ste pozabili vzeti odmerek, vzemite naslednji odmerek ob predvidenem času, pozabljeni odmerek pa izpustite.
English: The only metabolite of telotristat (active metabolite) representing consistently > 10% of total plasma drug-related material was its oxidative decarboxylated deaminated metabolite, LP-951757.
Slovenian: Edini presnovek telotristata (aktivni presnovek), ki konsistentno predstavlja > 10 % skupnega, z zdravilom povezanega materiala v plazmi, je njegov oksidativno dekarboksiliran in deaminiran presnovek LP-951757.
English: Pack sizes of 90 and 180 tablets.
Slovenian: Velikost pakiranj: 90 in 180 tablet.
English: Elderly patients (65 years of age and above) No specific dose recommendations are available for elderly patients (see section 5.2).
Slovenian: Starostniki (bolniki, stari 65 let in starejši) Pri starostnikih ni posebnih priporočil za odmerjanje (glejte poglavje 5.2).
English: In vitro, telotristat ethyl inhibited CES2 with an IC50 approximately of 6.4 μM.
Slovenian: Etiltelotristat je in vitro zaviral CES2, pri čemer je IC50 znašala približno 6,4 μM.
English: The majority was eliminated in the faeces.
Slovenian: Večina se je izločila z blatom.
English: The mean PK parameters for telotristat ethyl and the active metabolite appeared unchanged between week 24 and week 48, suggesting the achievement of steady-state conditions at or prior to week 24.
Slovenian: Povprečni farmakokinetični parametri etiltelotristata in aktivnega presnovka so med 24. in 48. tednom ostali nespremenjeni, kar kaže, da je stanje dinamičnega ravnovesja doseženo v ali pred 24. tednom.
English: Ipsen Pharma GmbH Einsteinstraße 174
Slovenian: Deutschland, Österreich Ipsen Pharma GmbH Einsteinstraße 174
English: They were generally of mild or moderate intensity.
Slovenian: Ti neželeni učinki so bili običajno blagi ali zmerni.
English: In patients with carcinoid syndrome, telotristat resulted in reductions in u5-HIAA (refer to Table 3 for TELESTAR and information provided for TELECAST).
Slovenian: Pri bolnikih s karcinoidnim sindromom je bila uporaba telotristata povezana z zmanjšanjem vrednosti u5-HIAA (glejte preglednico 3 za študijo TELESTAR in informacije, navedene za študijo TELECAST).
English: The mean age was 64 years (range 37 to 88 years), 52% were male and 90% were white.
Slovenian: Povprečna starost bolnikov je bila 64 let (razpon od 37 do 88 let), 52 % bolnikov je bilo moškega spola in 90 % bolnikov belcev.
English: Hepatic enzymes elevations
Slovenian: Zvišane vrednosti jetrnih encimov
English: Hviezdoslavova 19 SK-90301 Senec Tel: +421 905 667 410
Slovenian: SK-90301 Senec Tel: +421 905 667 410
English: Xermelo is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Xermelo ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: • medicines used to avoid transplant rejection, such as cyclosporine.
Slovenian: • zdravili za preprečevanje zavrnitve presadka, kot je ciklosporin.
English: • Breathing problems, rapid heartbeat, fever, incontinence (uncontrollable urination), confusion, dizziness or agitation.
Slovenian: • težave z dihanjem, hitro bitje srca, zvišana telesna temperatura, inkontinenca (nezmožnost zadrževanja urina), zmedenost, omotica ali vznemirjenost.
English: Administration of a single dose of 500 mg was well tolerated.
Slovenian: Uporabo enkratnega odmerka 500 mg so bolniki dobro prenašali.
English: Each tablet contains 168 mg of lactose (as anhydrous).
Slovenian: Ena tableta vsebuje 168 mg laktoze (brezvodne).
English: CLs were based on the HodgesLehmann estimator of the median paired difference.
Slovenian: IZ temeljijo na Hodges-Lehmann oceni mediane primerjane razlike.
English: Least Square mean difference 97.5% CL for difference p value
Slovenian: Povprečna razlika najmanjših kvadratov 97,5 % IZ za razliko p vrednost
English: This medicine is not recommended in patients below 18 years old.
Slovenian: Uporaba tega zdravila ni priporočljiva pri bolnikih, mlajših od 18 let, saj v tej starostni skupini uporaba tega zdravila ni bila raziskana.
English: All patients had well-differentiated metastatic neuroendocrine tumours and carcinoid syndrome.
Slovenian: Vsi bolniki so imeli dobro diferencirane metastatske nevroendokrine tumorje in karcinoidni sindrom.
English: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n° 16A-1°B
Slovenian: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n° 16A-1°B 1495 - 190 Algés
English: The proportions of patients reporting reductions from baseline in daily BM frequency (averaged over 12 weeks) were:
Slovenian: Deleži bolnikov, ki so navajali zmanjšanja dnevne pogostnosti odvajanja blata od izhodišča (v povprečju v 12 tednih) so bili:
English: It is unknown whether telotristat ethyl and its metabolite are excreted in human breast milk.
Slovenian: Ni znano, ali se etiltelotristat in njegov presnovek izločata v materino mleko.
English: Table 3: u5-HIAA excretion at baseline and week 12 (TELESTAR Study) Parameter
Slovenian: Preglednica 3: Izločanje u5-HIAA v izhodišču in 12. tednu (študija TELESTAR)
English: Contents of the pack and other information What Xermelo contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Xermelo
English: • The other ingredients are: lactose anhydrous (see section 2 under ‘Xermelo contains lactose'), hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, colloidal anydrous silica, polyvinyl alcohol (partially hydrolysed) (E1203), titanium dioxide (E171), macrogol 3350 (E1521) and talc (E553b).
Slovenian: • Druge sestavine so: brezvodna laktoza (glejte poglavje 2 ‘Zdravilo Xermelo vsebuje laktozo'), hidroksipropilceluloza, premreženi natrijev karmelozat, magnezijev stearat, koloidni brezvodni silicijev dioksid, polivinilalkohol (delno hidroliziran) (E1203), titanov dioksid (E171), makrogol 3350 (E1521) in smukec (E553b).
English: The primary endpoint was the percent change from Baseline in u5-HIAA at Week 12.
Slovenian: Primarni cilj študije je bil odstotna sprememba od izhodišča vrednosti u5-HIAA v 12. tednu.
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.
Slovenian: Ob koncu 12-tedenskega obdobja dvojno slepega zdravljenja je 115 bolnikov (85,2 %) vstopilo v 36-tedensko odprto podaljšano obdobje, kjer so vse bolnike titrirali na prejemanje višjega odmerka etiltelotristata (500 mg) trikrat na dan.
English: You should not breast-feed if you are taking Xermelo, as this medicine may be passed on to your baby.
Slovenian: Med jemanjem zdravila Xermelo ne smete dojiti, saj lahko to zdravilo s tem preide na otroka.
English: • medicines used to treat your neuroendocrine tumour, such as sunitinib or everolimus.
Slovenian: • zdravili za zdravljenje nevroendokrinega tumorja, kot sta sunitinib ali everolimus.
English: Systemic exposure to LP-951757 was about 35% of the systemic exposure to telotristat (active metabolite) in the mass balance study.
Slovenian: V študiji masnega ravnovesja je sistemska izpostavljenost LP-951757 znašala približno 35 % sistemske izpostavljenosti telotristatu (aktivnemu presnovku).
English: In a 26-week repeat-dose toxicity study in rats a No-Observed Adverse Effect Level (NOAEL) of 50 mg/kg/day was determined.
Slovenian: V 26-tedenski študiji toksičnosti ponavljajočih se odmerkov pri podganah je bila ugotovljena vrednost brez opaženih neželenih učinkov (NOAEL; “No-Observed Adverse Effect Level”), ki znaša 50 mg/kg/dan.
English: This might also be shown by changes in your blood test results, such as an increase of liver enzymes: gamma-glutamyl transferase (very common, may affect more than 1 in 10 people), transaminases and blood alkaline phosphatase (common, may affect up to 1 in 10 people).
Slovenian: To so lahko znaki nepravilnega delovanja jeter, kar lahko pokažejo tudi rezultati krvnih preiskav, kot so zvišanje vrednosti jetrnih encimov: gama-glutamiltransferaze (zelo pogost neželeni učinek, ki se lahko pojavi pri več kot 1 od 10 bolnikov), aminotransferaz in alkalne fosfataze (pogosta neželena učinka, ki se lahko pojavita pri največ 1 od 10 bolnikov).
English: Xermelo contains lactose (a type of sugar).
Slovenian: Zdravilo Xermelo vsebuje laktozo (vrsto sladkorja).
English: Other transporters Based on in vitro findings, no clinically-relevant interaction is expected with other transporters.
Slovenian: Drugi prenašalci Na osnovi in vitro izsledkov klinično pomembne interakcije z drugimi prenašalci niso pričakovane.
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.
Slovenian: Pri odmerkih 200 mg/kg/dan in 500 mg/kg/dan so poročali o degeneraciji/nekrozi v nežleznih in/ali žleznih delih želodca in/ali povečanju proteinskih kapljic v žleznih predelih.
English: Women of childbearing potential should be advised to use adequate contraception during treatment with telotristat.
Slovenian: Ženskam v rodni dobi je treba pojasniti, da morajo med zdravljenjem s telotristatom uporabljati učinkovito kontracepcijo.
English: • if you have end-stage kidney disease or are on dialysis.
Slovenian: • če imate končno odpoved ledvic ali se zdravite z dializo.
English: The potential of telotristat ethyl as an inducer of CYP3A4 was not assessed at concentrations expectable at the intestinal level, due to its low solubility in vitro.
Slovenian: Potencial etiltelotristata kot induktorja CYP3A4 ni bil ocenjen pri koncentracijah, pričakovanih v črevesju, zaradi njegove nizke topnosti in vitro.
English: There is no relevant use of telotristat in the paediatric population in the indication of carcinoid syndrome.
Slovenian: Pediatrična populacija Telotristat ni namenjen za uporabo pri pediatrični populaciji za indikacijo karcinoidni sindrom.
English: • Impacted stools (bowel obstruction, faecaloma), you may experience, constipation, watery diarrhoea, pale skin (anaemia), nausea, vomiting, weight loss, back pain or stomach pains particularly after eating or a reduction in passing water (urination).
Slovenian: • Fekalna impakcija (črevesna zapora, fekalom); pojavijo se lahko zaprtje, vodena driska, bleda koža (anemija), slabost, bruhanje, izguba telesne teže, bolečina v hrbtu ali bolečine v želodcu, zlasti po obroku, ali zmanjšano izpraznjevanje sečnega mehurja (uriniranje).
English: • medicines used to treat epilepsy, such as valproic acid.
Slovenian: • zdravili za zdravljenje epilepsije, kot je valprojska kislina.
English: For clinical management of elevated hepatic enzymes, see section 4.4.
Slovenian: Za klinično ukrepanje v primeru zvišanja vrednosti jetrnih encimov glejte poglavje 4.4.
English: Laboratory monitoring of hepatic enzymes prior to and during telotristat therapy is recommended as clinically indicated.
Slovenian: Priporočljivo je laboratorijsko spremljanje vrednosti jetrnih encimov pred uvedbo zdravljenja in med zdravljenjem s telotristatom, kot je klinično indicirano.
English: After oral administration, telotristat ethyl undergoes hydrolysis via carboxylesterases to its active and major metabolite.
Slovenian: Po peroralni uporabi se etiltelotristat hidrolizira s karboksilesterezami do svojega aktivnega in glavnega presnovka.
English: In vitro telotristat ethyl inhibited BCRP (IC50 = 20 µM), but its active metabolite telotristat did not show any significant inhibition of BCRP activity (IC50 > 30 µM).
Slovenian: Etiltelotristat je in vitro zaviral BCRP (IC50 = 20 µM), vendar pa njegov aktivni presnovek telotristat ni pokazal pomembnega zaviranja aktivnosti BCRP (IC50 > 30 µM).
English: 90 film-coated tablets 180 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 90 filmsko obloženih tablet 180 filmsko obloženih tablet
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.
Slovenian: Pri sočasni uporabi zdravila Xermelo se lahko zmanjša učinkovitost zdravil, ki so substrati za CYP2B6 (npr. valprojska kislina, bupropion, sertralin), zaradi zmanjšanja njihove sistemske izpostavljenosti.
English: In vitro, telotristat ethyl inhibited CYP3A4, suggesting a potential interaction with CYP3A4 substrates.
Slovenian: Etiltelotristat je in vitro zaviral CYP3A4, kar kaže na možno interakcijo s substrati za CYP3A4.
English: This is when a tumour, called a ‘neuroendocrine tumour', releases a substance called serotonin into your bloodstream.
Slovenian: imenovan ‘nevroendokrini tumor', sprošča snov, imenovano serotonin, v vaš krvni obtok.
English: Ipsen Farmaceutica B.V. Taurusavenue 33b 2132 LS Hoofddorp Tel: + 31 (0) 23 554 1600
Slovenian: Taurusavenue 33b 2132 LS Hoofddorp Tel: + 31 (0) 23 554 1600
English: Your doctor may decide to decrease your daily dose of Xermelo.
Slovenian: Zdravnik se lahko odloči za zmanjšanje dnevnega odmerka zdravila Xermelo.
English: Fatigue may occur following administration of telotristat (see section 4.8).
Slovenian: Po uporabi telotristata se lahko pojavi utrujenost (glejte poglavje 4.8).
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.
Slovenian: Ena tableta je približno 17 mm dolga in 7,5 mm široka z vtisnjeno oznako ‘T-E' na eni in ‘250' na drugi strani.
English: - if you are allergic to telotristat or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Xermelo: - če ste alergični na telotristat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: b. Defined as the proportion of responders with ≥30% reduction in daily number of BMs for ≥50%
Slovenian: b. Opredeljen kot delež bolnikov z odzivom z ≥ 30 % zmanjšanjem dnevnega števila odvajanj blata za ≥ 50 % časa v obdobju dvojno slepega zdravljenja.
English: Tell your doctor immediately if you notice any of the following side effects:
Slovenian: Takoj obvestite zdravnika, če opazite katerega koli izmed naslednjih neželenih učinkov:
English: These studies confirmed that telotristat did not increase the incidence of tumors in both species and sexes, at doses corresponding to an exposure of approximately 10- to 15-fold and 2- to 4.5-fold the human exposure to the active metabolite at the MRHD in mice and rats, respectively.
Slovenian: Te študije so potrdile, da telotristat ni povečal pojavnosti tumorjev pri obeh vrstah in spolih pri odmerkih, ki pri miših ustrezajo približno 10-kratni do 15-kratni izpostavljenosti človeka aktivnemu presnovku pri največjem priporočenem odmerku za človeka, pri podganah pa približno 2-kratni do 4,5-kratni izpostavljenosti človeka aktivnemu presnovku pri največjem priporočenem odmerku za človeka.
English: Following a single 500 mg oral dose of 14C-telotristat ethyl, approximately 93% of the dose was recovered.
Slovenian: Po enkratnem 500-mg peroralnem odmerku 14C-etiltelotristata se je izločilo približno 93 % odmerka.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
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.
Slovenian: V celoti je bilo 18 bolnikov (13,2 %) predčasno izključenih iz študije med obdobjem dvojno slepega zdravljenja, 7 bolnikov v skupini s placebom, 3 bolniki v skupini z etiltelotristatom v odmerku 250 mg in 8 bolnikov v skupini z višjim odmerkom.
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).
Slovenian: Tako predzdravilo (etiltelotristat) kot njegov aktivni presnovek (telotristat) sta zaviralca L-triptofan hidroksilaz (TPH1 in TPH2, ki omejujeta hitrost biosinteze serotonina).
English: On the basis of the scientific conclusions for telotristat the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing telotristat is unchanged subject to the proposed changes to the product information.
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za telotristat odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) telotristat nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: In patients with hepatic impairment, continuous monitoring for adverse events and worsening of liver function is recommended.
Slovenian: Pri bolnikih z okvaro jeter je priporočljivo neprekinjeno spremljanje neželenih učinkov in poslabšanja delovanja jeter.
English: If you feel tired, you should wait until you feel better before driving or using any tools or machines.
Slovenian: Če ste utrujeni, morate pred pričetkom upravljanja vozil, orodij ali strojev počakati, da utrujenost izzveni.
English: In vitro telotristat (active metabolite) caused a concentration dependent increase in CYP2B6 mRNA levels (>2-fold increase and > 20% of the positive control, with a maximum observed effect similar to the positive control), suggesting possible CYP2B6 induction (see section 4.5).
Slovenian: CYP2B6 (za > 2-krat zvišanje in > 20 % od pozitivne kontrole, z najvišjim opazovanim učinkom podobnim pozitivni kontroli), kar kaže na možno indukcijo CYP2B6 (glejte poglavje 4.5).
English: If you have liver problems, your doctor may decide to reduce your daily dose of Xermelo.
Slovenian: Če imate težave z jetri, lahko zdravnik dnevni odmerek zdravila Xermelo zmanjša.
English: Special populations
Slovenian: Posebne populacije Starostniki
English: There is limited clinical experience with telotristat overdose in humans.
Slovenian: Kliničnih izkušenj s prevelikim odmerjanjem telotristata pri človeku je malo.
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.
Slovenian: Študija je vključevala 12-tedensko obdobje dvojno slepega zdravljenja, v katerem so bolniki v začetku prejemali placebo (n=45), etiltelotristat v odmerku 250 mg (n=45) ali v višjem odmerku (etiltelotristat v odmerku 500 mg; n=45) trikrat na dan.
English: All patients had well-differentiated metastatic neuroendocrine tumour with carcinoid syndrome.
Slovenian: Vsi bolniki so imeli dobro diferenciran nevroendokrini tumor s karcinoidnim sindromom.
English: The use of telotristat is not recommended in patients with severe hepatic impairment (Child Pugh score C) as no data are available (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter (ocena C po Child Pugh) uporaba telotristata ni priporočljiva, saj podatki niso na voljo (glejte poglavje 5.2).
English: c Faecaloma has only been observed in a clinical study at a dosage of 500mg tid (twice the recommended dose).
Slovenian: c Fekalno impakcijo (fekalom) so opazili le v klinični študiji, v kateri je bil uporabljen odmerek 500 mg trikrat na dan (dvakratni priporočeni odmerek).
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.
Slovenian: V to študijo so vključili osem oseb s hudo do zmerno okvaro ledvic, ki niso potrebovale zdravljenja z dializo [ocenjena hitrost glomerulne filtracije (eGFR) ≤ 33 ml/min ob presejanju in ≤ 40 ml/min na dan pred uporabo odmerka] ter osem oseb z normalnim delovanjem ledvic oziroma največ blago okvaro ledvic [eGFR ≥ 88 ml/min ob presejanju in ≥ 83 ml/min na dan pred uporabo odmerka].
English: A study was conducted to investigate the impact of renal impairment on the pharmacokinetics of a single dose of telotristat ethyl 250 mg.
Slovenian: Izvedena je bila študija, ki je raziskala vpliv okvare ledvic na farmakokinetiko enkratnega 250-mg odmerka etiltelotristata.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Vpliv drugih zdravil na zdravilo Xermelo
English: • medicines used to lower cholesterol levels, such as simvastatin.
Slovenian: • zdravili za zniževanje vrednosti holesterola, kot je simvastatin.
English: • Feeling tired or weak (fatigue)
Slovenian: • občutek utrujenosti ali oslabelosti
English: The use of telotristat is not recommended in patients with severe hepatic impairment as no data are available.
Slovenian: Pri bolnikih s hudo okvaro jeter uporaba telotristata ni priporočljiva, saj podatki niso na voljo.
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).
Slovenian: Ko je bil opažen popoln učinek telotristata (v zadnjih 6 tednih dvojno slepega zdravljenja), je delež bolnikov z odzivom v obliki zmanjšanja pogostnosti odvajanja blata za vsaj 30 % v skupini z odmerkom 250 mg znašal 51 % (23/45) v primerjavi z 22 % (10/45) v skupini s placebom (post-hoc analiza).
English: They were on SSA therapy and had ≥4 daily BM.
Slovenian: Zdravili so se z analogom somatostatina in so imeli ≥ 4 odvajanj blata na dan.
English: The most frequently reported adverse reaction leading to discontinuation of telotristat was abdominal pain in 7.1% of patients (5/70).
Slovenian: Najpogosteje poročani neželeni učinek, zaradi katerega je bilo treba zdravljenje s telotristatom prekiniti, je bila bolečina v trebuhu pri 7,1 % bolnikov
English: Elevations in hepatic enzymes were observed in clinical studies (see section 4.8).
Slovenian: V kliničnih študijah so opazili zvišane vrednosti jetrnih encimov (glejte poglavje 4.8).
English: • feeling or being sick, abnormally dark urine, yellow skin or eyes, pain in the upper right belly.
Slovenian: • siljenje na bruhanje ali bruhanje, nenormalno temen urin, rumeno obarvanje kože ali očesnih beločnic, bolečina v zgornjem desnem predelu trebuha.
English: • Depression, you may experience decreased self-esteem, lack of motivation, sadness or low mood
Slovenian: • depresija, ki se lahko odraža s slabo samopodobo, pomanjkanjem motivacije, žalostjo ali slabim razpoloženjem Občasni neželeni učinki:
English: Statistically significant reductions in u5-HIAA were seen for telotristat ethyl 250 mg tid compared with placebo in both Phase 3 studies.
Slovenian: Statistično pomembno zmanjšanje vrednosti u5-HIAA je bilo pri uporabi etiltelotristata v odmerku 250 mg trikrat na dan v primerjavi s placebom opaženo v obeh študijah 3. faze.
English: It is not known how telotristat may affect the baby.
Slovenian: Morebiten vpliv telotristata na otroka ni znan.