FrancophonIA/ELRC3.0 huggingface dataset:
English: When the threshold for abdominal pain response was increased to ≥40% or ≥50% improvement from baseline in daily worst abdominal pain, the proportion of abdominal pain responders was 6%-7% higher for eluxadoline 100 mg twice daily compared to placebo which was statistically significant (P ≤ 0.009) for the pooled (Study 1 and Study 2) data.
Croatian: Kada je prag za odgovor u pogledu boli u abdomenu povećan na poboljšanje od ≥40% ili ≥50% u odnosu na početnu vrijednost u dnevnoj najgoroj boli u abdomenu, udio bolesnika koji su odgovorili na liječenje u pogledu boli u abdomenu bio je 6%-7% viši za eluksadolin 100 mg dvaput na dan u usporedbi s placebom, što je bilo statistički značajno (P ≤0,009) za objedinjene podatke (Ispitivanje 1 i
English: Abdominal distention Gastroesophageal reflux disease4
Croatian: povraćanje flatulencija distenzija abdomena gastroezofagealna refluksna bolest4
English: Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline and there were no serious complications of constipation related to eluxadoline use in pivotal studies.
Croatian: Stope teške konstipacije bile su manje od 1% u bolesnika koji su primali 75 mg i 100 mg eluksadolina i nije bilo ozbiljnih komplikacija konstipacije povezanih uz primjenu eluksadolina u ključnim ispitivanjima.
English: Also, eluxadoline significantly improves patients quality of life as demonstrated by change from baseline score in the IBS-QOL questionnaire at weeks 12 and 26.
Croatian: Nadalje, eluksadolin značajno poboljšava kvalitetu života bolesnika, što je dokazano promjenom u odnosu na početne vrijednosti upitnika IBS-QOL u 12. i 26. tjednu.
English: In vitro studies demonstrated that eluxadoline was stable in human hepatocytes, liver and intestinal microsomes, and that the only minor and inactive metabolite of eluxadoline detected was the acyl glucuronide metabolite (M11) formed through glucuronidation of the methoxybenzoic acid moiety.
Croatian: In vitro ispitivanja pokazala su da je eluksadolin stabilan u ljudskim hepatocitima, jetrenim i crijevnim mikrosomima i da je detektiran jedino manji i neaktivni metabolit eluksadolina bio acil-glukuronid (M11), nastao glukuronidacijom dijela metoksibenzoatne kiseline.
English: Improvements in global symptoms of IBS were assessed based on an adequate relief response endpoint defined as achieving adequate relief of IBS symptoms on at least 50% of weeks and on a global symptom response endpoint defined by a daily rating of global symptoms of none or mild on at least 50% of days.
Croatian: Poboljšanje u globalnim simptomima IBS-a ocijenjeno je na temelju odgovarajuće mjere ishoda odgovora u pogledu ublažavanja, definirane kao postizanje odgovarajućeg ublažavanja simptoma IBS-a u najmanje 50% tjedana i na mjeri ishoda odgovora u pogledu globalnih simptoma, definirane kao dnevna ocjena globalnih simptoma kao nepostojećih ili blagih u najmanje 50% dana.
English: Although exposure of eluxadoline was significantly increased in ESRD participants not yet on dialysis compared with matched, healthy participants with normal renal function, such an increase is unlikely to be of clinical significance because the geometric mean Cmax and AUC0-t in the participants with ESRD was in the same range as observed in several larger studies in healthy volunteers.
Croatian: Iako je izloženost eluksadolinu značajno povećana u bolesnika sa završnim stadijem bolesti bubrega koji još nisu na dijalizi u usporedbi s njima odgovarajućim, zdravim sudionicima s normalnom funkcijom bubrega, nije vjerojatno da je takvo povećanje klinički značajno jer je srednja geometrijska vrijednost za Cmax i AUC0-t u sudionika sa završnim stadijem bolesti bubrega bila u istom rasponu koji je zabilježen u nekoliko većih ispitivanja u zdravih dobrovoljaca.
English: It is unlikely that Truberzi will affect your ability to drive or use tools or machines.
Croatian: Malo je vjerojatno da će Truberzi utjecati na sposobnost upravljanja vozilima ili rada s alatima ili strojevima.
English: Eluxadoline is also an agonist at the kappa opioid receptor (κOR).
Croatian: Eluksadolin je također agonist na kapa-opioidnim receptorima (κOR).
English: Single supratherapeutic oral doses of eluxadoline up to 1,000 mg and single intranasal doses up to 200 mg were associated with a higher incidence of adverse events than a 100 mg single dose, especially gastrointestinal and central nervous system events.
Croatian: Jednokratne supraterapijske oralne doze eluksadolina do najviše 1000 mg, i jednokratne intranazalne doze do najviše 200 mg bile su povezane s većom incidencijom štetnih događaja nego jednokratna doza od 100 mg, a naročito događajima u probavnom sustavu i središnjem živčanom sustavu.
English: Hypersensitivity6
Croatian: Preosjetljivost6
English: There is a potential for increased risk of somnolence and sedation when taking eluxadoline (see section 4.8) in patients who may experience increased plasma levels, such as in patients with a genetic predisposition for poor function of OATP1B1 transporter.
Croatian: Postoji mogućnost povećanog rizika od somnolencije i sedacije tijekom uzimanja eluksadolina (vidjeti dio 4.8) u bolesnika koji mogu imati povećane razine u plazmi, kao što su bolesnici s genetskom predispozicijom za slabo funkcioniranje prijenosnika OATP1B1.
English: In the event of naloxone administration, subjects should be monitored closely for the return of overdose symptoms, which may indicate need for repeated naloxone injection.
Croatian: U slučaju primjene naloksona, treba pažljivo nadzirati osobe kako bi se uočio povratak simptoma predoziranja, što može ukazivati na potrebu za ponavljanjem injekcije naloksona.
English: Considering the short half-life of naloxone, repeated administration may be necessary.
Croatian: Budući da nalokson ima kratki poluvijek, može biti potrebna ponovljena primjena.
English: Truberzi may increase the level of some medicines in the blood.
Croatian: Truberzi može povećati razinu određenih lijekova u krvi.
English: Additionally, the proportion of patients who were composite responders to eluxadoline at each 4-week interval for months 1 through 6 was higher than placebo for both doses in both Phase 3 studies demonstrating that efficacy is maintained with continuous eluxadoline treatment.
Croatian: Uz to, udio bolesnika koji su imali kompozitni odgovor na liječenje eluksadolinom u svakom 4-tjednom razdoblju od 1. do 6. mjeseca bio je veći nego za placebo za obje doze u oba ispitivanja faze 3, što dokazuje da se djelotvornost održava kontinuiranim liječenjem lijekom eluksadolinom.
English: Film-coated tablets 28 tablets
Croatian: Filmom obložene tablete 28 tableta
English: For patients who are unable to tolerate the 200 mg daily dose (one 100 mg tablet, twice daily), the dose can be lowered to 150 mg daily (one 75 mg tablet twice daily).
Croatian: Za bolesnike koji ne podnose dnevnu dozu od 200 mg (jedna tableta od 100 mg dvaput na dan), doza se može smanjiti na 150 mg dnevno (jedna tableta od 75 mg dva puta na dan).
English: Following single oral 100 mg dose in subjects with varying degrees of liver impairment and healthy subjects, eluxadoline plasma levels were on average 6-fold, 4-fold, and 16-fold elevated in mild, moderate, and severe hepaticimpaired subjects (Child Pugh Class A, B, C), respectively, while half-life increased 3-5 fold (see sections 4.3 and 4.4).
Croatian: Nakon jednokratne oralne doze od 100 mg u ispitanika s različitim stupnjevima oštećenja funkcije jetre i zdravih ispitanika, razine eluksadolina u plazmi bile su u prosjeku za 6 puta, 4 puta i 16 puta povećane u ispitanika s blagim, umjerenim, odnosno teškim oštećenjem funkcije jetre (Child Pugh stadij A, B, C), dok je poluvijek porastao 3-5 puta (vidjeti dijelove 4.3 i 4.4).
English: Eluxadoline should not be administered concomitantly with such medicinal products (see section 4.3).
Croatian: Eluksadolin se ne smije primijeniti istodobno s takvim lijekovima (vidjeti dio 4.3).
English: 1% of patients receiving 75 mg and 2% of patients receiving 100 mg discontinued treatment or temporarily suspended dosing secondary to constipation, respectively, compared to <1% of patients treated with placebo.
Croatian: 1% bolesnika koji su primali 75 mg i 2% bolesnika koji su primali 100 mg prekinulo je liječenje ili je privremeno prekinulo doziranje radi konstipacije, u usporedbi sa <1% bolesnika koji su primali placebo.
English: However, in a clinical study in healthy subjects, administration of eluxadoline 100 mg twice daily for one week, with a single oral dose of 4 mg of midazolam resulted in no change to the midazolam Cmax and a slight decrease in AUC (~10%).
Croatian: Ipak, u kliničkim ispitivanjima na zdravim ispitanicima primjena eluksadolina u dozi od 100 mg dva puta dnevno tijekom jednog tjedna, uz jednokratnu dozu midazolama od 4 mg peroralno, nije utjecala na Cmax midazolama, uz blagi pad vrijednosti AUC (~10%).
English: Truberzi is a medicine that contains the active substance eluxadoline.
Croatian: Truberzi je lijek koji sadrži djelatnu tvar eluksadolin.
English: How to take Truberzi
Croatian: Kako uzimati Truberzi
English: Systemic exposure to medicinal products metabolised by CYP3A4 may be decreased when coadministered with Eluxadoline.
Croatian: Sistemska izloženost lijekovima koji se metaboliziraju pomoću CYP3A4 može se smanjiti kada se primjenjuju istodobno s eluksadolinom.
English: If this dosage is well tolerated, but not sufficiently effective, dosage may subsequently be increased to 200 mg daily (one 100 mg tablet twice daily).
Croatian: Ako se ta doza dobro podnosi, ali nije dovoljno učinkovita, doza se naknadno može povećati na 200 mg dnevno
English: Avoid taking Truberzi with any other medicines that may cause constipation such as opioids (e.g. fentanyl [used to treat pain]) or anticholinergics (e.g. atropine [used to treat cardiac disorders among other indications]).
Croatian: Izbjegavajte uzimanje lijeka Truberzi s bilo kojim drugim lijekom koji može izazvati zatvor poput opioida (npr. fentanil [koristi se za liječenje boli]) ili antikolinergici (npr. atropin [koristi se za liječenje srčanih poremećaja uz druge indikacije]).
English: The frequency of serious adverse events, gastrointestinal events, and events leading to discontinuation tended to be lower for the 75 mg dose compared to the 100 mg dose.
Croatian: Učestalost ozbiljnih štetnih događaja, gastrointestinalnih događaja i događaja koji su doveli do prekida liječenja bila je manja pri dozi od 75 mg u odnosu na dozu od 100 mg.
English: Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.
Croatian: Gubitak djelotvornosti naročito može nastupiti kada se lijekovi u niskim dozama i s uskim terapijskim indeksom (npr. alfentanil, dihidroergotamin, ergotamin, fentanil, pimozid, kinidin, sirolimus, takrolimus) primjenjuju istodobno s eluksadolinom.
English: The occurrence of such events in patients with an intact biliary tract cannot be excluded.
Croatian: Ne može se isključiti pojava takvih događaja u bolesnika s intaktnim žučovodom.
English: • A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.
Croatian: • Kronična ili teška konstipacija, ili posljedice konstipacije, ili utvrđena ili suspektna mehanička gastrointestinalna opstrukcija u anamnezi.
English: In clinical studies, events of sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain in 8 patients, pancreatitis in 1 patient and abdominal pain with lipase elevation less than 3 times the upper limit of normal in 1 patient.
Croatian: U kliničkim ispitivanjima su se događaji spazma Oddijevog sfinktera manifestirali kao porast jetrenih enzima povezan s boli u abdomenu u 8 bolesnika, pankreatitis u 1 bolesnika i bol u abdomenu s porastom lipaze manjim od trostruke vrijednosti iznad gornje granice normale u 1 bolesnika.
English: The main symptoms of IBS-D include: - stomach ache; - stomach discomfort; - diarrhoea; - urgent bowel movements.
Croatian: Glavni simptomi IBS-D-a uključuju: - bol u trbuhu; - nelagodu u trbuhu; - proljev; - hitno pražnjenje crijeva.
English: Truberzi acts on the surface of your gut to restore the normal function of your bowels and block the sensation of pain and discomfort in IBS-D patients.
Croatian: Truberzi djeluje na površini crijeva kako bi uspostavio normalnu funkciju crijeva te zaustavio osjećaj boli i nelagode u bolesnika s IBS-D-om.
English: There is an increased risk of pancreatitis with or without sphincter of Oddi spasm (see section 4.3) in patients taking eluxadoline.
Croatian: Postoji povećani rizik od pankreatitisa sa ili bez spazma Oddijevog sfinktera (vidjeti dio 4.3) u bolesnika koji uzimaju eluksadolin.
English: Do not use this medicine after the expiry date which is stated on blister and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake 'Rok valjanosti'.
English: Stop taking Truberzi, and seek medical attention immediately if you have new or worsening stomach pain, with or without nausea and vomiting, while taking Truberzi.
Croatian: Prestanite uzimati Truberzi i odmah potražite medicinsku pomoć ako imate novu bol ili pogoršanje postojeće boli u trbuhu, sa ili bez mučnine i povraćanja, dok uzimate Truberzi.
English: Given eluxadoline's action at opioid receptors, administration of a narcotic mu opioid antagonist, such as naloxone, should be considered.
Croatian: S obzirom na to da eluksadolin djeluje na opioidne receptore, treba uzeti u obzir primjenu narkotičkog antagonista mi opioidnih receptora, kao što je nalokson.
English: Patients should be instructed to stop the medicinal product and seek medical attention if these symptoms develop while taking eluxadoline (see section 4.8).
Croatian: Bolesnike treba savjetovati da prekinu uzimati lijek i potraže liječničku pomoć ako se ti simptomi razviju dok uzimaju eluksadolin (vidjeti dio 4.8).
English: Film-coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc (E553b); iron oxide yellow (E172) and iron oxide red (E172).
Croatian: Film-ovojnica: poli(vinilni alkohol) (E1203); titanijev dioksid (E171); makrogol 3350 (E1521); talk (E553b); žuti željezov oksid (E172) i crveni željezov oksid (E172).
English: It is unknown whether eluxadoline is excreted in human milk.
Croatian: Nije poznato izlučuje li se eluksadolin u majčino mlijeko.
English: Patients should be instructed to stop the treatment immediately and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain (e.g. acute epigastric or biliary [i.e., right upper quadrant] pain) that may radiate to the back or shoulder, with or without nausea and vomiting.
Croatian: Bolesnike treba uputiti da odmah prekinu liječenje i potraže liječničku pomoć ako se pojave simptomi koji ukazuju na spazam Oddijevog sfinktera poput akutnog pogoršanja boli u abdomenu (npr. akutna epigastrična ili žučna [tj. u desnom gornjem kvadrantu] bol) koja se može širiti prema leđima ili ramenu, sa ili bez mučnine i povraćanja.
English: However, given the potential for increased sensitivity to experience undesirable effects, it may be considered to initiate eluxadoline treatment in a dosage of 150 mg daily (one 75 mg tablet twice daily).
Croatian: Međutim, zbog mogućnosti povećane osjetljivosti na pojavu nuspojava, može se razmotriti početak liječenja eluksadolinom u dozi od 150 mg dnevno (jedna tableta od 75 mg dva puta na dan).
English: Co-administration of OATP1B1 inhibitors (cyclosporine, gemfibrozil, antiretrovirals [atazanavir, lopinavir, ritonavir, saquinavir, tipranavir], rifampin) with eluxadoline may increase exposure to eluxadoline (see section 5.2).
Croatian: Istodobna primjena inhibitora OATP1B1 (ciklosporin, gemfibrozil, antiretrovirotici [atazanavir, lopinavir, ritonavir, sakvinavir, tipranavir], rifampicin) s eluksadolinom može povećati izloženost eluksadolinu (vidjeti dio 5.2).
English: Eluxadoline is a locally acting, mixed mu opioid receptor (μOR) agonist and delta opioid receptor
Croatian: Eluksadolin je lokalno djelujući, miješani agonist mi-opioidnih receptora (μOR) i antagonist deltaopioidnih receptora (δOR).
English: MRP2 inhibitors
Croatian: Inhibitori MRP2
English: Eluxadoline increases the exposure of the co-administered OATP1B1 substrate; rosuvastatin (see section 5.2) by up to 40% of the total exposure which is usually not considered to be clinically relevant.
Croatian: Supstrati OATP1B1 Eluksadolin povećava izloženost istodobno primijenjenom supstratu OATP1B1, rosuvastatinu (vidjeti dio 5.2) do 40% od ukupne izloženosti koja se obično ne smatra klinički relevantnom.
English: Patients should be instructed to stop the medicinal product and seek medical attention if they develop severe constipation (see section 4.4).
Croatian: Bolesnike treba uputiti da prekinu uzimati lijek i potraže medicinsku pomoć ako se javi teška konstipacija (vidjeti dio 4.4).
English: All events of sphincter of Oddi spasm occurred in patients without a gallbladder.
Croatian: Svi događaji spazma Oddijevog sfinktera nastupili su u bolesnika koji nisu imali žučni mjehur.
English: Patients with known or suspected sphincter of Oddi disease or dysfunction and/or biliary tract or pancreatic disease, including a history of pancreatitis, must not receive Truberzi (see section 4.3).
Croatian: Bolesnici s utvrđenom ili suspektnom bolesti ili disfunkcijom Oddijevog sfinktera i/ili bolesti žučnih vodova ili gušterače, uključujući pankreatitis u anamnezi, ne smiju primati Truberzi (vidjeti dio 4.3).
English: Postmarketing serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder.
Croatian: Nakon stavljanja lijeka u promet prijavljene su ozbiljne nuspojave spazma Oddijevog sfinktera sa ili bez pankreatitisa koje su završile hospitalizacijom, prvenstveno u bolesnika bez žučnog mjehura.
English: Given the mu opioid receptor agonism of eluxadoline, there is a potential for increased risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (eg, biliary-type pain) in patients taking eluxadoline, especially in patients without a gallbladder (see sections 4.3 and 4.8).
Croatian: S obzirom na to da je eluksadolin agonist mi-opioidnog receptora, postoji mogućnost povećanog rizika od spazma Oddijevog sfinktera, s posljedičnim pankreatitisom ili porastom jetrenih enzima povezanim s akutnom boli u abdomenu (npr. bilijarnom vrstom boli) u bolesnika koji uzimaju eluksadolin, naročito u bolesnika koji nemaju žučni mjehur (vidjeti dijelove 4.3 i 4.8).
English: The use of eluxadoline with other medicinal products that may cause constipation (for example anticholinergics, opioids etc) should also be avoided.
Croatian: Treba također izbjegavati primjenu eluksadolina s drugim lijekovima koji mogu izazvati konstipaciju (na primjer antikolinergici, opioidi i sl.).
English: • Patients on treatment with potent inhibitors of OATP1B1 (e.g. cyclosporine)
Croatian: • Bolesnici koji se liječe potentnim inhibitorima OATP1B1 (npr. ciklosporin).
English: During the 4 week single-blind withdrawal period in Study 2 (IBS-3002), no evidence of rebound diarrhoea or abdominal pain was demonstrated.
Croatian: Tijekom 4-tjednog jednostruko slijepog razdoblja ustezanja od lijeka u Ispitivanju 2 (IBS-3002), nije bilo dokaza proljeva ili boli u abdomenu nastalih kao posljedica ustezanja od lijeka.
English: Patients receiving eluxadoline also reported significant reductions in bowel movement frequency and abdominal bloating compared to placebo as demonstrated by changes from baseline in daily bowel movements and bloating score at Weeks 12 and 26.
Croatian: Bolesnici koji su primali eluksadolin također su prijavili značajna smanjenja u učestalosti pražnjenja crijeva i nadutosti abdomena u usporedbi s placebom što je dokazano promjenama u odnosu na početne vrijednosti u dnevnim pražnjenjima crijeva i ocjeni nadutosti u 12. i 26. tjednu.
English: Eluxadoline has demonstrated efficacy in normalizing GI transit and defecation in several models of stress induced or post GI inflammation-altered GI function in animals.
Croatian: Eluksadolin je pokazao djelotvornost u normaliziranju prolaza kroz GI trakt i defekacije u nekoliko životinjskih modela kod poremećaja gastrointestinalne funkcije inducirane stresom ili nastale nakon gastrointestinalne upale.
English: Film-coated tablets Multipack: 168 (3 packs of 56) tablets.
Croatian: Filmom obložene tablete Višestruko pakiranje: 168 (3 pakiranja od 56) tableta.
English: An abuse liability study with 100 mg and 200 mg intranasal doses of eluxadoline resulted in higher systemic concentrations of eluxadoline that produced changes in pupil diameter but were associated with drug disliking.
Croatian: Ispitivanje utjecaja na zlouporabu s intranazalnim dozama od 100 mg i 200 mg eluksadolina rezultiralo je višim sistemskim koncentracijama eluksadolina, što je izazvalo promjene u promjeru zjenice, ali je bilo povezano s odbojnošću prema lijeku.
English: Core tablet: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); crospovidone, type B (E1202); mannitol (E421) and magnesium stearate (E572).
Croatian: Jezgra tablete: silicifirana mikrokristalična celuloza (E460); koloidni, bezvodni silicijev dioksid (E551); krospovidon, tip B (E1202); manitol (E421) i magnezijev stearat (E572).
English: Hepatic impairment or coadministration with cysclosporine results in significant increases in plasma concentrations of eluxadoline.
Croatian: Oštećenje funkcije jetre ili istodobna primjena sa ciklosporinom rezultira značajnim povećanjima koncentracije eluksadolina u plazmi.
English: Study 2 (IBS-3002) included a 4-week single-blinded, placebo-withdrawal period upon completion of the 26-week treatment period.
Croatian: Ispitivanje 2 (IBS-3002) obuhvaćalo je 4-tjedno jednostruko slijepo razdoblje ustezanja od lijeka uz primjenu placeba nakon dovršetka razdoblja liječenja od 26 tjedana.
English: Truberzi is available in packs containing 28 or 56 film-coated tablets and in a multipack of 168 film-coated tablets comprising 3 cartons, each containing 56 film-coated tablets.
Croatian: Lijek Truberzi je raspoloživ u pakiranjima od 28 ili 56 filmom obloženih tableta te u višestrukom pakiranju od 168 filmom obloženih tableta koje se sastoji od 3 kutije, a svaka sadrži 56 filmom obloženih tableta.
English: Eluxadoline has a minor influence on the ability to drive and use machines.
Croatian: Eluksadolin malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: 3 “Sphincter of Oddi spasm” term includes: manifestation as pancreatitis (terms include alcoholic pancreatitis, pancreatitis, and pancreatitis acute) and hepatic enzyme elevations with abdominal pain (terms include abdominal pain, abdominal pain upper, dyspepsia, and sphincter of Oddi dysfunction).
Croatian: 3 Pojam „spazam Oddijevog sfinktera“ obuhvaća: manifestacije kao što su pankreatitis (pojmovi obuhvaćaju alkoholni pankreatitis, pankreatitis i akutni pankreatitis) i porast jetrenih enzima s boli u abdomenu (pojmovi obuhvaćaju bol u abdomenu, bol u gornjem dijelu abdomena, dispepsiju i disfunkciju Oddijevog sfinktera).
English: Film-coated tablets 56 tablets.
Croatian: Filmom obložene tablete 56 tableta.
English: Abdominal Pain Response
Croatian: Odgovor u pogledu boli u abdomenu
English: The European Medicines Agency has deferred the obligation to submit the results of clinical studies with Truberzi in one or more subsets of the paediatric population in IBS-D (see section 4.2 for information on paediatric use).
Croatian: Truberzi u jednoj ili više podskupina pedijatrijske populacije s dijagnozom IBS-D-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).