FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if you notice any of the following side effects:
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava:
English: 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.
Croatian: 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.
English: PVC/PCTFE/PVC/Al blister The blisters are packaged in a carton.
Croatian: PVC/PCTFE/PVC/Al blister
English: Other CYPs Based on in vitro findings, no clinically-relevant interaction is expected with other cytochromes P450.
Croatian: Na temelju podataka dobivenih in vitro ne očekuju se klinički značajne interakcije s drugim enzimima citokroma P450.
English: If you feel tired, you should wait until you feel better before driving or using any tools or machines.
Croatian: Ako osjećate umor, trebate pričekati, a upravljati vozilima ili rukovati alatima ili strojevima možete tek kad se budete bolje osjećali.
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).
Croatian: 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).
English: Fatigue may occur following administration of telotristat (see section 4.8).
Croatian: Nakon primjene telotristata može se pojaviti umor (vidjeti dio 4.8).
English: • The active substance is telotristat ethyl.
Croatian: • Djelatna tvar je etiltelotristat.
English: How Xermelo works
Croatian: Kako Xermelo djeluje
English: Selise 26 - 11
Croatian: CentralPharma Communications OÜ Selise 26 - 11
English: 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).
Croatian: 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).
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.
Croatian: 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.
English: If you forget to take a dose, take your next dose when it is due, skipping the missed dose.
Croatian: Ako ste zaboravili uzeti dozu, preskočite tu propuštenu dozu i uzmite sljedeću prema svom uobičajenom rasporedu.
English: 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).
Croatian: 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).
English: • Wind
Croatian: • vrućica
English: In rats decrease in brain serotonin (5-HT) was observed at doses≥1,000 mg/kg/day of telotristat etiprate per os.
Croatian: U štakora je opaženo smanjenje razine serotonina u mozgu (5-HT) kada je telotristatetiprat davan peroralno u dozama ≥ 1000 mg/kg na dan.
English: 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.
Croatian: 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.
English: Loperamide caused a <30% decrease in the formation of telotristat (active metabolite) in vitro (see section 5.2).
Croatian: Loperamid je in vitro prouzročio smanjenje stvaranja telotristata (aktivni metabolit) od < 30% (vidjeti dio 5.2).
English: They were on SSA therapy and had ≥4 daily BM.
Croatian: Liječeni su terapijom SSA-om, a broj pražnjenja crijeva iznosio im je ≥ 4 dnevno.
English: Telotristat ethyl 250 mg tid
Croatian: Etiltelotristat 250 mg TID
English: 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.
Croatian: 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.
English: 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).
Croatian: 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.
English: What Xermelo is used for
Croatian: Za što se Xermelo koristi
English: b. Defined as the proportion of responders with ≥30% reduction in daily number of BMs for ≥50%
Croatian: 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
English: 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.
Croatian: 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.
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.
Croatian: 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.
English: Acid Reducers
Croatian: Lijekovi koji smanjuju želučanu kiselinu
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.
Croatian: 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.
English: How to take Xermelo
Croatian: Kako uzimati Xermelo
English: Telotristat ethyl and its active metabolite were not shown to be inducers of CYP3A4 at systemically relevant concentrations, based on in vitro findings.
Croatian: Na temelju podataka dobivenih in vitro pokazalo se da etiltelotristat i njegov aktivni metabolit nisu induktori CYP3A4 u sistemski relevantnim koncentracijama.
English: The influence of age on the pharmacokinetics of telotristat ethyl and its active metabolite has not been conclusively evaluated.
Croatian: Učinak dobi na farmakokinetiku etiltelotristata i njegova aktivnog metabolita nije procijenjen dovoljno za donošenje zaključka.
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.
Croatian: 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.
English: D-81677 München Tel.: +49 89 262043289
Croatian: Tel.: +49 89 262043289
English: Ipsen Pharma, s.r.o.
Croatian: Česká republika Ipsen Pharma, s.r.o.
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).
Croatian: U skupini koja je primala etiltelotristat 250 mg, bilo je 40% bolesnika (10/25) s postojanim odgovorom (kako je definirano u tablici 2) naspram 0% u skupini koja primala placebo (0/26) (p = 0,001).
English: Based on the high inter-subject variability observed, accumulation in a subset of patients with CS cannot be excluded.
Croatian: Na temelju opažene visoke varijabilnosti između ispitanika, akumulacija u podskupu bolesnika s karcinoidnim sindromom ne može se isključiti.
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”.
Croatian: Na temelju podataka iz kliničkih ispitivanja i razdoblja nakon stavljanja lijeka u promet preporučuje se ažuriranje dijela 4.8 SmPC-a kako bi se unutar klasifikacije organskih sustava, pod Poremećaje probavnog sustava, uključilo mučninu kao nuspojavu s učestalošću „vrlo često“.
English: Al. Jana Pawła II 29
Croatian: Ipsen Poland Sp. z o.o. Al. Jana Pawła II 29 00-867 Warszawa
English: Figure 1 - Mean change from baseline in BMs by study week during the DBT period, Intent-toTreat Population
Croatian: Slika 1 - Srednja vrijednost promjene u broju pražnjenja crijeva u odnosu na početnu vrijednost po tjednima ispitivanja tijekom razdoblja dvostruko slijepog liječenja, populacija predviđena za liječenje
English: In rabbits the NOAEL for maternal and prenatal toxicity is 125 mg/kg/d corresponding to 1.5 to 4 times the estimated human exposure (AUC0-24) of the active metabolite LP-778902 at the MRHD.
Croatian: U kunića NOAEL za maternalnu i prenatalnu toksičnost iznosi 125 mg/kg na dan, što za MRHD aktivnog metabolita LP-778902 odgovara vrijednosti od 1,5 do 4 x procijenjene izloženosti u ljudi (AUC0-24).
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”.
Croatian: Završno, preporučuje se u dio 4.8 SmPC-a i dio 4 Upute o lijeku pod psihijatrijske poremećaje nadodati depresiju i depresivno raspoloženje, s učestalošću „često“.
English: • oral contraceptives, such as ethinyloestradiol.
Croatian: • kontraceptive koji se uzimaju na usta, kao što je etinilestradiol
English: Xermelo contains anhydrous lactose as an excipient.
Croatian: Xermelo sadrži bezvodnu laktozu kao pomoćnu tvar.
English: The NOAEL for parental / maternal / prenatal and postnatal toxicity is 500 mg/kg/day in rats corresponding to 3 to 4 times the estimated human exposure (AUC0-24) of the active metabolite LP-778902 at the MRHD.
Croatian: Vrijednost NOAEL-a za roditeljsku / maternalnu / prenatalnu i postnatalnu toksičnost iznosi u štakora 500 mg/kg na dan, što za MRHD aktivnog metabolita LP-778902 odgovara vrijednosti 3 do 4 x procijenjene izloženosti u ljudi (AUC0-24).
English: Primary endpoint: change from baseline in BMs/day averaged over 12 weeks
Croatian: Primarna mjera ishoda: promjena broja pražnjenja crijeva/dan u odnosu na početak, uprosječena za 12 tjedana
English: In the 12-week DBT period of the study, average weekly reductions in BM frequency on telotristat were observed as early as 3 weeks, with the greatest reductions occurring during the last 6 weeks of the DBT period, compared with placebo (refer to Figure 1).
Croatian: U usporedbi s placebom, u 12-tjednom razdoblju dvostruko slijepog liječenja u ispitivanju prosječna tjedna smanjenja učestalosti pražnjenja crijeva opažena su uz telotristat već nakon 3 tjedna, s tim da su najveća smanjenja bila u posljednjih 6 tjedana tog razdoblja (vidjeti sliku 1).
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).
Croatian: Distenzija abdomena zabilježena je u 7,1% bolesnika (5/70) koji su primali etiltelotristat 250 mg TID, naspram 4,2% u skupini koja primala placebo (3/71).
English: Xermelo 250 mg film-coated tablets
Croatian: NAZIV LIJEKA Xermelo 250 mg filmom obložene tablete
English: What Xermelo is and what it is used for What Xermelo is
Croatian: Što je Xermelo i za što se koristi
English: • Belly (abdominal) pain
Croatian: Vrlo česte nuspojave: • bol u trbuhu (abdomenu)
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.
Croatian: Zbog slabe topljivosti in vitro potencijal etiltelotristata kao induktora CYP3A4 nije bio procijenjen u koncentracijama koje se očekuju na razini crijeva.
English: Very common side effects:
Croatian: Manje česte nuspojave:
English: Telotristat ethyl 250 mg showed that stool consistency, as measured by Bristol Stool Form Scale, was improved compared with placebo.
Croatian: Bristol Stool Form Scale) poboljšala u usporedbi s placebom.
English: The mean number of daily BM at baseline was 2.2 and 2.5 respectively in the placebo (n=25) and 250 mg group (n=25).
Croatian: Srednja vrijednost broja pražnjenja crijeva na dan bila je na početku 2,2 u skupini koja je primala placebo (n = 25) i 2,5 u skupini liječenoj dozom od 250 mg etiltelotristata (n = 25).
English: 20 (44.4)c BM = bowel movement; CL=confidence limit; tid=three times daily; SD=standard deviation.
Croatian: CL= granica pouzdanosti; TID = tri puta na dan; SD = standardna devijacija. a.
English: Following a single 500 mg oral dose of 14C-telotristat ethyl, approximately 93% of the dose was recovered.
Croatian: C-etiltelotristata, otkriveno je približno 93% doze.
English: Kalnciema iela 33-5 Rīga
Croatian: Ipsen Pharma pārstāvniecība Latvijā Kalnciema iela 33-5
English: It is also recommended that the MAH should add the ADR “intestinal obstruction” to the section 4.8 of the SmPC and section 4 of PL with the frequency “uncommon”.
Croatian: Također, preporučuje se da nositelj odobrenja za stavljanje lijeka u promet u dio 4.8 SmPC-a i dio 4 Upute o lijeku doda nuspojavu „opstrukcija crijeva“, s učestalošću „manje često“.
English: The mean u5-HIAA excretion at baseline was 69.1 mg/24hours in the 250 mg group (n=17) and
Croatian: Srednja vrijednost izlučivanja u5-HIAA bila je na početku 69,1 mg/24 sata u skupini koja je primala 250 mg (n = 17) i 84,8 mg/24 sata u skupini koja je primala placebo (n = 22).
English: You may feel sick or be sick, have diarrhoea or stomach ache.
Croatian: Ako uzmete više lijeka Xermelo nego što ste trebali Možete osjećati mučninu ili povraćati, imati proljev ili bol u trbuhu.
English: How to store Xermelo
Croatian: Kako čuvati Xermelo
English: Constipation was reported in 5.7% of patients (4/70) in the telotristat ethyl 250 mg group and in 4.2% of patients (3/71) in the placebo group.
Croatian: Konstipacija je zabilježena u 5,7% bolesnika (4/70) u skupini koja je primala etiltelotristat 250 mg i 4,2% bolesnika (3/71) u skupini koja je primala placebo.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika,ljekarnika ili medicinsku sestru.
English: The change from baseline in daily BM averaged over 12 weeks was +0.1 and -0.5 in the placebo and 250 mg groups respectively.
Croatian: Promjena u broju pražnjenja crijeva na dan u odnosu na početak ispitivanja, uprosječena za 12 tjedana, bila je +0,1 u skupini koja je primala placebo te -0,5 u skupini koja je primala 250 mg etiltelotristata.
English: France, Hrvatska
Croatian: France, Hrvatska Ipsen Pharma
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.
Croatian: No-Observed Adverse Effect Level, NOAEL) od 50 mg/kg na dan.
English: 00-867 Warszawa Tel.: + 48 22 653 68 00
Croatian: Tel.: + 48 22 653 68 00
English: Telotristat ethyl 250 mg tid u5-HIAA excretion (mg/24 hours) at baseline
Croatian: Izlučivanje u5-HIAA (mg/24 sata) na početku
English: Each tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl.
Croatian: Jedna tableta sadrži telotristatetiprat u količini koja odgovara 250 mg etiltelotristata.
English: Telotristat reduces bowel movement (BM) frequency.
Croatian: Telotristat smanjuje učestalost pražnjenja crijeva.
English: It is recommended to reassess the benefit of continued therapy in a patient not responding within this time period.
Croatian: U bolesnika u kojih se u tom razdoblju ne postigne odgovor, preporučuje se ponovno procijeniti korist od nastavka terapije.
English: Reduced exposures were not observed in a 12◦week double-blind, placebo-controlled, randomised,
Croatian: Smanjene izloženosti nisu opažene u 12-tjednom dvostruko slijepom, placebom kontroliranom, randomiziranom, multicentričnom kliničkom ispitivanju u odraslih bolesnika s karcinoidnim sindromom na terapiji dugodjelujućim SSA-om.
English: • feeling or being sick (unexplained nausea or vomiting), abnormally dark urine, yellow skin or eyes,
Croatian: • mučnina ili povraćanje (iz neobjašnjivih razloga), neuobičajeno tamna mokraća, žuta boja kože ili bjeloočnica, bol u gornjoj desnoj strani trbuha.
English: Number of patients Baseline mean (SD)
Croatian: Srednja vrijednost na početkua (SD)
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.
Croatian: Flatulencija je opažena u 5,7% bolesnika (4/70) u skupini koja je primala etiltelotristat u dozi od 250 mg i 1,4% (1/71) u onoj koja primala placebo.
English: a. Baseline data based on all patients with data at baseline.
Croatian: Početni podaci svih bolesnika za koje su postojali podaci na početku ispitivanja.
English: of time over the DBT period.
Croatian: ROK VALJANOSTI Rok valjanosti
English: Abdominal distension, Constipation, Flatulence
Croatian: Poremećaji probavnog sustava bol u abdomenua, mučnina distenzija abdomena konstipacija flatulencija fekalomc, opstrukcija crijeva
English: Each film-coated tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži telotristatetiprat u količini koja odgovara 250 mg etiltelotristata.
English: A pre-specified patient exit interview substudy was conducted to assess relevance and clinical meaningfulness of symptom improvements in 35 patients.
Croatian: Kako bi se procijenila važnost i klinička značajnost poboljšanja simptoma, u 35 bolesnika provedeno je prethodno određeno podispitivanje s intervjuom bolesnika na izlasku iz ispitivanja.
English: Gammaglutamyltransferase increasedb
Croatian: Tablični prikaz nuspojava
English: In patients with carcinoid syndrome on long-acting SSA therapy, there was also a rapid conversion of telotristat ethyl to its active metabolite.
Croatian: Konverzija etiltelotristata u njegov aktivni metabolit bila je brza i u bolesnika s karcinoidnim sindromom na terapiji dugodjelujućim SSA-om.
English: Patients with a mean reduction of at least 1.5 BM per day: 46.7% (telotristat ethyl 250 mg) and 20.0% (placebo);
Croatian: Udjeli bolesnika za koje je zabilježeno smanjenje u dnevnoj učestalosti pražnjenja crijeva u odnosu na početak (uprosječeno za 12 tjedana) bili su: - bolesnici sa srednjom vrijednošću smanjenja od najmanje 1 pražnjenja crijeva na dan: 66,7% (etiltelotristat 250 mg) i 31,1% (placebo) - bolesnici sa srednjom vrijednošću smanjenja od najmanje 1,5 pražnjenja crijeva na dan: 46,7% (etiltelotristat 250 mg) i 20,0% (placebo) - bolesnici sa srednjom vrijednošću smanjenja od najmanje 2 pražnjenja crijeva na dan: 33,3% (etiltelotristat 250 mg) i 4,4% (placebo).
English: Transporters
Croatian: Drugi prijenosnici
English: Headache
Croatian: Dojenje
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.
Croatian: Etiltelotristat inhibirao je P-gp in vitro, ali njegov aktivni metabolit nije pri klinički značajnim koncentracijama.
English: Mean Change from Baseline (and 95% CL) in Bowel Movements (counts/day)
Croatian: Srednja vrijednost promjene u broju pražnjenja crijeva na dan u odnosu na početak (i 95% CL)
English: This is approximately 14 times the human exposure (AUC total) at the maximum recommended human dose (MRHD) of 750 mg/day for the active metabolite LP-778902.
Croatian: To je za aktivni metabolit LP-778902 približno 14 x izloženosti u ljudi (ukupni AUC) pri maksimalnoj preporučenoj dozi za ljude (engl. maximum recommended human dose, MRHD) od 750 mg na dan.
English: This is approximately 20 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Croatian: To je za aktivni metabolit LP-778902 približno 20 x izloženosti u ljudi (ukupni AUC) pri MRHD-u od 750 mg na dan.
English: This is approximately 0.4 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Croatian: To je za aktivni metabolit LP-778902 približno 0,4 x izloženosti u ljudi (ukupni AUC) pri MRHD-u od 750 mg na dan.
English: Interactions
Croatian: Parametar
English: This is approximately 21 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Croatian: To je za aktivni metabolit LP-778902 približno 21 x izloženosti u ljudi (ukupni AUC) pri MRHD-u od 750 mg na dan.
English: Cytochromes
Croatian: Interakcije Citokromi
English: Tablet core
Croatian: Drugi CYP-ovi
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.
Croatian: C-etiltelotristata iznosio je približno 0,6 sata, a aktivnog metabolita 5 sati.
English: Auto-injectors were invented in the 1960s following military research in the United States of America (USA).
Croatian: Automatske brizgalice razvijene su u 1960.-ima nakon vojnog istraživanja u Sjedinjenim Američkim Državama (SAD-u).
English: Grounds for the CHMP opinion Whereas
Croatian: Razlozi za mišljenje CHMP-a
English: The conditions affecting the marketing authorisations are set out in Annex IV.
Croatian: Uvjeti koji utječu na izdavanje odobrenja za stavljanje lijeka u promet navedeni su u Prilogu IV.
English: The first adrenaline auto-injectors (AAI) were developed and introduced into the medical market approximately 25 years ago in the USA.
Croatian: Prve automatske brizgalice za adrenalin (AAI-ovi) razvijene su i stavljene u promet na tržište lijekova otprilike prije 25 godina u SAD-u.