FrancophonIA/ELRC3.0 huggingface dataset:
English: Eluxadoline must not be used in patients with a history of or known or suspected hepatic impairment (Child-Pugh Class A-C) (see section 4.3).
Croatian: Eluksadolin se ne smije primjenjivati u bolesnika koji u anamnezi imaju utvrđeno ili suspektno oštećenje funkcije jetre (Child-Pugh stadij A-C) (vidjeti dio 4.3).
English: Serious adverse reactions of pancreatitis (0.2% and 0.3% of patients receiving 75 mg and 100 mg respectively) and sphincter of Oddi spasm (0.2% of patients receiving 75 mg and 0.8% of patients receiving 100 mg) may also occur.
Croatian: Mogu se također pojaviti ozbiljne nuspojave poput pankreatitisa (0,2% i 0,3% bolesnika koji su primali 75 mg, odnosno 100 mg) i spazma Oddijevog sfinktera (0,2% bolesnika koji su primali 75 mg i 0,8% bolesnika koji su primali 100 mg).
English: A relevant proportion of patients diagnosed with IBS-D may be affected by bile-acid malabsorption as a potential reason for IBS-D symptoms.
Croatian: Malapsorpcija žučne kiseline Kod značajnog udjela bolesnika s dijagnozom IBS-D-a može se javiti malapsorpcija žučne kiseline kao mogući razlog za pojavu IBS-D simptoma.
English: Co-administration of eluxadoline with rosuvastatin (an OATP1B1 substrate) resulted in an up to 1.4-fold increase in exposure of rosuvastatin and the major active metabolite, n-desmethyl rosuvastatin compared to administration of rosuvastatin alone.
Croatian: Istodobna primjena eluksadolina s rosuvastatinom (supstratom OATP1B1) rezultirala je porastom za 1,4 puta u izloženosti rosuvastatinu i glavnom aktivnom metabolitu, n-dezmetil rosuvastatinu u usporedbi s primjenom samog rosuvastatina.
English: Eluxadoline's systemic exposure following oral administration is low and is consistent with its local action in the GI tract.
Croatian: Sistemska izloženost eluksadolinu nakon peroralne primjene je niska i u skladu s lokalnim djelovanjem u GI traktu.
English: Co-administration of eluxadoline with probenecid (MRP2 inhibitor) resulted in approximately 1.4-fold increase in exposure to eluxadoline.
Croatian: Istodobna primjena eluksadolina s probenecidom (inhibitorom MRP2) rezultirala je porastom za približno 1,4 puta u izloženosti eluksadolinu.
English: Caution should be exercised when administering eluxadoline in IBS patients whose bowel habits vary over time.
Croatian: Potreban je oprez prilikom primjene eluksadolina u bolesnika s IBS-om čiji se ritam pražnjenja crijeva mijenja tijekom vremena.
English: • A history of pancreatitis; or known or suspected structural diseases of the pancreas, including pancreatic duct obstruction.
Croatian: • Pankreatitis u anamnezi, ili utvrđene ili suspektne strukturne bolesti gušterače, uključujući opstrukciju gušteračnog voda.
English: In vitro studies indicated that eluxadoline is a substrate and an inhibitor of the hepatic uptake transporter OATP1B1; a substrate for the hepatic efflux transporter MRP2 and is not a substrate or inhibitor of the P-gp and BCRP transporters.
Croatian: In vitro ispitivanja pokazala su da je eluksadolin supstrat i inhibitor prijenosnika jetrenog unosa OATP1B1; supstrat prijenosnika jetrenog efluksa MRP2 i da nije supstrat niti inhibitor prijenosnika P-gp-a i BCRP-a.
English: Most of the reported cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with eluxadoline and some developed symptoms after one to two doses.
Croatian: Većina prijavljenih slučajeva ozbiljnog spazma Oddijevog sfinktera pojavila se unutar tjedan dana od početka liječenja eluksadolinom, a neki su bolesnici razvili simptome čak i nakon jedne do dvije doze.
English: BSS <5 Response
Croatian: Odgovor u pogledu BSS-a
English: In both studies, the proportion of patients who were composite responders to Truberzi 100 mg twice daily was statistically significantly higher than placebo.
Croatian: U oba ispitivanja, udio bolesnika koji su bili bolesnici s kompozitnim odgovorom na liječenje lijekom Truberzi 100 mg dvaput na dan bio je statistički značajno viši nego kod placeba.
English: Pack sizes of 28, 56 and a multipack containing 168 (3 packs of 56) film-coated tablets.
Croatian: Veličine pakiranja od 28, 56 te višestruko pakiranje koje sadrži 168 (3 pakiranja od 56) filmom obloženih tableta.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - 100 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - 100 mg
English: All patients met Rome III criteria for IBS and were required to meet the following criteria:
Croatian: Svi su bolesnici zadovoljili Rimske kriterije III za IBS, a morali su zadovoljiti i sljedeće kriterije: • prosječni bodovi najgore boli u abdomenu (eng. worst abdominal pain, WAP) u posljednja
English: These patients are at risk for significantly increased plasma concentrations of eluxadoline (see sections 4.4 and 5.2).
Croatian: U tih bolesnika postoji rizik od značajno povećanih koncentracija eluksadolina u plazmi (vidjeti dijelove 4.4 i 5.2).
English: In participants with end stage renal disease (ESRD) not yet on dialysis, exposure of eluxadoline was significantly increased compared with matched, healthy participants with normal renal function.
Croatian: U sudionika sa završnim stadijem bolesti bubrega koji još nisu na dijalizi, izloženost eluksadolinu značajno je povećana u usporedbi s njima odgovarajućim zdravim sudionicima s normalnom funkcijom bubrega.
English: Stop taking Truberzi and call your doctor right away if you develop severe constipation while taking Truberzi.
Croatian: Prestanite uzimati Truberzi i odmah se javite svom liječniku ako imate teški oblik zatvora dok uzimate Truberzi.
English: There is limited amount of data from the use of eluxadoline in pregnant women.
Croatian: Podaci o primjeni eluksadolina u trudnica su ograničeni.
English: Efficacy of eluxadoline was assessed using an overall responder analyses as defined by the simultaneous improvement in the daily WAP score by ≥30% as compared to the baseline weekly average AND a reduction in the BSS to <5 on at least 50% of the days within a time interval.
Croatian: Djelotvornost eluksadolina ocijenjena je primjenom cjelokupne analize bolesnika koji su odgovorili na liječenje kako je definirano simultanim poboljšanjem bodova dnevnog WAP-a za ≥30% u usporedbi s tjednim prosjekom na početku ispitivanja i smanjenjem BSS-a na <5 u najmanje 50% dana unutar određenog vremenskog razdoblja.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - 75 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - 75 mg
English: Eluxadoline may cause constipation.
Croatian: Eluksadolin može uzrokovati konstipaciju.
English: Patients should be informed of and monitored for signs and symptoms suggestive of pancreatitis e.g. abdominal pain, that may radiate to the back or shoulder, nausea and vomiting.
Croatian: Bolesnike treba upoznati sa simptomima i znakovima koji ukazuju na pojavu pankreatitisa, a liječnik treba bolesnike nadzirati na pojavu istih, kao primjerice boli u abdomenu koja se može širiti prema leđima ili ramenu, mučninu i povraćanje.
English: Each tablet contains 100 mg of eluxadoline.
Croatian: Jedna tableta sadrži 100 mg eluksadolina.
English: The most common adverse reactions (incidence of >5%) reported were constipation (7% and 8% of patients receiving 75 mg and 100 mg respectively), nausea (8% and 7% of patients receiving 75 mg and 100 mg respectively) and abdominal pain (6% and 7% of patients receiving 75 mg and 100 mg respectively).
Croatian: Sažetak sigurnosnog profila Najčešće prijavljivane nuspojave (incidencija od >5%) bile su konstipacija (7% i 8% bolesnika koji su primali 75 mg, odnosno 100 mg), mučnina (8% i 7% bolesnika koji su primali 75 mg, odnosno
English: It is used to treat irritable bowel syndrome (‘IBS') with diarrhoea (IBS-D) in adults.
Croatian: Koristi se za liječenje sindroma iritabilnog crijeva (IBS) s proljevom (engl. irritable bowel syndrome with diarrhoea, IBS-D) u odraslih.
English: These medicines can include: - ciclosporin (immunosuppressant used to reduce inflammation); - gemfibrozil (used to lower lipid levels); - atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV); - rifampicin (antibiotic used to treat infections).
Croatian: - ciklosporin (imunosupresiv koji se koristi za smanjivanje upale); - gemfibrozil (koristi se za smanjivanje razine lipida); - atazanavir, lopinavir, ritonavir, sakvinavir, tipranavir (antiretrovirotici koji se koriste za liječenje infekcije HIV-om);
English: Eluxadoline is primarily excreted in the feces, either as unabsorbed active substance or via the biliary system with the kidney playing a minimal role in elimination.
Croatian: Biotransformacija Eluksadolin se prvenstveno izlučuje putem fecesa, bilo kao neapsorbirana djelatna tvar ili putem bilijarnog sustava, pri čemu bubreg ima minimalnu ulogu u eliminaciji.
English: Eluxadoline is primarily cleared as such via the biliary system with the kidney playing a minimal role in elimination.
Croatian: Eluksadolin se prvenstveno uklanja neizmijenjen putem bilijarnog sustava, pri čemu bubreg ima minimalnu ulogu u eliminaciji.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Truberzi Lijek čuvajte izvan pogleda i dohvata djece.
English: 2“Abdominal pain" term includes: abdominal pain, abdominal pain lower, and abdominal pain upper.
Croatian: 2 Pojam „bol u abdomenu“ obuhvaća: bol u abdomenu, bol u donjem dijelu abdomena i bol u gornjem dijelu abdomena.
English: Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D).
Croatian: Truberzi je indiciran u odraslih za liječenje sindroma iritabilnog crijeva s proljevom (engl. irritable bowel syndrome with diarrhoea, IBS-D).
English: Unchanged eluxadoline recovered in urine was 0.01% and 0.05% of dose in ESRD and healthy participants, respectively.
Croatian: Nepromijenjeni eluksadolin izlučen u mokraći iznosio je 0,01 % odnosno 0,05 % doze primijenjene u sudionika sa završnim stadijem bolesti bubrega odnosno zdravih sudionika.
English: 5 “Rash" term includes: dermatitis, dermatitis allergic, rash, rash generalized, rash macula-papular, rash papular, rash pruritic, urticaria, and idiopathic urticarial.
Croatian: 5 Pojam „osip“ obuhvaća: dermatitis, alergijski dermatitis, osip, generalizirani osip, makulopapularni osip, papularni osip, pruritični osip, urtikariju i idiopatsku urtikariju.
English: Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with eluxadoline and some patients developed symptoms even after one to two doses but cases of pancreatitis after longer duration of treatment have also been reported.
Croatian: Većina prijavljenih slučajeva ozbiljnog pankreatitisa pojavila se unutar tjedan dana od početka liječenja eluksadolinom, a neki bolesnici razvili su simptome čak i nakon jedne do dvije doze.
English: (see section 4.5).
Croatian: (vidjeti dio 4.8).
English: Patients with renal impairment No dose adjustment is necessary based on renal function (see sections 4.4 and 5.2).
Croatian: Nije potrebno prilagođavati dozu prema bubrežnoj funkciji (vidjeti dijelove 4.4 i 5.2).
English: • an average of worst abdominal pain (WAP) scores in the past 24 hours of >3.0 on a 0 to 10 scale over the week prior to randomization.
Croatian: 24 sata od >3,0 na ljestvici od 0 do 10 tijekom tjedna prije randomizacije.
English: The efficacy results for ≥50% of responder days (primary composite endpoint) over 6 months are shown in Table 2.
Croatian: Rezultati djelotvornosti za ≥50% dana s odgovorom na liječenje (primarni kompozitni ishod) tijekom
English: Eluxadoline is not an inducer/inhibitor of major CYP enzymes, however, eluxadoline has some potential for the metabolism based inactivation of CYP3A4.
Croatian: Eluksadolin ne djeluje kao induktor/inhibitor glavnih enzima CYP, međutim, eluksadolin ima određene mogućnosti inaktivacije
English: The apparent clearance of eluxadoline is markedly reduced and half-life increases in hepatic-impaired patients (see sections 4.3 and 4.4).
Croatian: Prividni klirens eluksadolina značajno je smanjen, a poluvijek se povećava u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.3 i 4.4).
English: These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm (see section 4.4).
Croatian: U tih je bolesnika povećan rizik od nastanka ozbiljnih nuspojava pankreatitisa i/ili spazma Oddijevog sfinktera (vidjeti dio 4.4).
English: Each tablet contains 75 mg of eluxadoline.
Croatian: Jedna tableta sadrži 75 mg eluksadolina.
English: The following adverse reactions considered related to eluxadoline treatment from clinical trials and spontaneous reporting are presented according to the MedDRA System Organ Classification and frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Sljedeće nuspojave za koje se smatra da su povezane s liječenjem eluksadolinom, prikupljene izkliničkih ispitivanja i spontanog prijavljivanja, prikazane su u skladu s MedDRA klasifikacijom organskih sustava i kategorijama učestalosti: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često
English: These symptoms occur uncommonly (may affect up to 1 in 100 people) and may indicate pancreas or bile duct system problems (e.g. inflammation of the pancreas or spasm of the sphincter of Oddi).
Croatian: Ti se simptomi pojavljuju manje često (mogu se javiti u manje od 1 na 100 osoba) i mogu ukazivati na probleme s gušteračom ili žučovodom (npr. na upalu gušterače ili spazam Oddijevog sfinktera).
English: No dose adjustment is necessary for co-administered OATP1B1 substrates.
Croatian: Nije potrebno prilagođavati dozu za istodobno primijenjene supstrate OATP1B1.
English: Given eluxadoline's local action in the GI tract, low Foral and lack of metabolism, prospective clinical studies regarding differences in age, body mass index (BMI), ethnicity, and gender were deemed unnecessary.
Croatian: smatralo se da su nepotrebna prospektivna klinička ispitivanja u vezi razlika u dobi, indeksu tjelesne mase (ITM), etničkog podrijetla i spola.
English: Eluxadoline is a substrate of the hepatic efflux transporter MRP2.
Croatian: Eluksadolin je supstrat prijenosnika jetrenog efluksa MRP2.
English: • these symptoms are uncommon and may indicate pancreas or bile duct system problems (i.e. inflammation of the pancreas or spasm of the sphincter of Oddi); o your risk of developing pancreas or bile duct system problems may be higher if you drink alcohol in excess, o the spasm of the sphincter of Oddi usually goes away when you stop Truberzi.
Croatian: • ti su simptomi manje česti i mogu ukazivati na probleme s gušteračom ili žučovodom (tj. na upalu gušterače ili spazam Oddijevog sfinktera); o rizik od pojave problema s gušteračom ili žučovodom može biti veći ako prekomjerno konzumirate alkohol,
English: Following a single oral dose of 300 mg [14C] eluxadoline in healthy male subjects, 82.2% of the total [14C] eluxadoline was recovered in faeces in 336 hours and less than 1% was recovered in urine in 192 hours.
Croatian: ukupnog [14C] eluksadolina pronađeno je u fecesu u roku od 336 sati i manje od 1% pronađeno je u urinu u roku od 192 sata.
English: OATP1B1 inhibitors
Croatian: Inhibitori OATP1B1
English: Truberzi should not be restarted in patients who developed biliary duct obstruction or sphincter of Oddi spasm while taking Truberzi (see section 4.3).
Croatian: Liječenje lijekom Truberzi ne smije se ponovo započeti u bolesnika u kojih se javila opstrukcija žučnih kanala ili spazam Oddijevog sfinktera tijekom uzimanja lijeka Truberzi (vidjeti dio 4.3).
English: OATP1B1 substrates
Croatian: Supstrati OATP1B1
English: The usual recommended dose is one 100 mg tablet twice a day.
Croatian: Uobičajena preporučena doza je jedna tableta od 100 mg dvaput na dan.
English: The proportion of patients who were adequate relief responders was statistically significantly higher than placebo for Truberzi 100 mg twice daily over 6 month interval in both studies.
Croatian: Udio bolesnika koji je odgovorio na liječenje odgovarajućim ublažavanjem simptoma bio je statistički značajno viši uz lijek Truberzi 100 mg dvaput na dan nego kod placeba tijekom razdoblja od 6 mjeseci u oba ispitivanja.
English: (called ‘IBS with constipation' [IBS-C]); - if you have, or may have, a blockage in your intestine/bowels; - If you take medicines that may increase the level of the concentration of eluxadoline in the blood (so-called OATP1B1 inhibitor, e.g. ciclosporin).
Croatian: - ako ste imali zatvor neko vrijeme ili ako je zatvor glavni simptom vašeg IBS-a (zove se ‘IBS sa zatvorom' [engl. irritable bowel syndrome with constipation, IBS-C]); - ako imate, ili možda imate, začepljenje u crijevima; - ako uzimate lijekove koji mogu povećati razinu koncentracije eluksadolina u krvi (takozvani inhibitor OATP1B1, npr. ciklosporin).
English: However, patients 65 years of age and older, treated with the 75 mg dose twice daily experienced a reduced rate of serious adverse events as well as adverse events leading to discontinuation compared to patients treated with 100 mg dose twice daily (see section 4.8).
Croatian: 75 mg dvaput na dan imali su manju stopu ozbiljnih štetnih događaja kao i štetnih događaja koji su doveli do prekida liječenja u usporedbi s bolesnicima liječenima dozom od 100 mg dva puta na dan
English: The recommended dose is 200 mg daily (one 100 mg tablet, twice daily).
Croatian: Preporučena doza je 200 mg dnevno (jedna tableta od 100 mg dva puta na dan).
English: Table 2: Efficacy Results in Randomized Clinical Studies Study 1 (IBS 3001)
Croatian: Tablica 2: Rezultati djelotvornosti u randomiziranim kliničkim ispitivanjima
English: These medicines can include: - rosuvastatin (statin used to treat high cholesterol and to prevent cardiovascular disease); - valsartan and olmesartan (used to treat high blood pressure);
Croatian: Ti lijekovi mogu uključivati: - rosuvastatin (statin koji se koristi za liječenje visokog kolesterola i sprječavanje kardiovaskularne bolesti);
English: Package leaflet: Information for the patient Truberzi 100 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za bolesnika Truberzi 100 mg filmom obložene tablete eluksadolin
English: The recommended dose is one 100 mg tablet twice a day.
Croatian: Preporučena doza je jedna tableta od 100 mg dvaput na dan.
English: These patients are at increased risk for acute pancreatitis (see section 4.4).
Croatian: U tih je bolesnika povećan rizik od akutnog pankreatitisa (vidjeti dio 4.4).
English: In vitro studies in human liver microsomes showed that eluxadoline is not a direct inhibitor of CYP3A4 at clinically relevant concentrations [IC50 =450 µM] but in human intestinal microsomes, eluxadoline was a metabolism dependent inhibitor of CYP3A4 with kinact of 0.1 min-1 and K-I of 450 µM (256 µg/mL).
Croatian: CYP3A4 pri klinički značajnim koncentracijama [IC50 =450 µM], dok je u ljudskim crijevnim mikrosomima eluksadolin bio o metabolizmu ovisan inhibitor CYP3A4, s vrijednošću kinact od 0,1 min
English: Assessment of drug interactions
Croatian: Procjena interakcija s drugim lijekovima
English: These patients are at increased risk for sphincter of Oddi spasm (see section 4.4).
Croatian: U tih je bolesnika povećan rizik od spazma Oddijevog sfinktera (vidjeti dio 4.4).
English: Of the 5 cases reported, 3 were associated with excessive alcohol intake, 1 was associated with biliary sludge, and in one case the patient discontinued eluxadoline 2 weeks prior to the onset of symptoms.
Croatian: Od 5 prijavljenih slučajeva, 3 su bila povezana s pretjeranim unosom alkohola, 1
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 100 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija - 100 mg
English: In a population pharmacokinetic analysis, the estimated apparent volume of distribution of eluxadoline was 27,100 L. In healthy subjects, eluxadoline was moderately (81%) bound to plasma proteins.
Croatian: U zdravih ispitanika, eluksadolin se umjereno (81%) veže za proteine plazme.
English: Additional cases of pancreatitis not associated with sphincter of Oddi spasm were reported in clinical studies.
Croatian: U kliničkim ispitivanjima prijavljeni su dodatni slučajevi pankreatitisa nepovezanog sa spazmom
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 75 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija - 75 mg
English: Truberzi 100 mg film-coated tablets Each film-coated tablet contains 100 mg of eluxadoline.
Croatian: Truberzi 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg eluksadolina.
English: 6”Hypersensitivity” term includes: anaphylaxis, angioedema, (e.g. swollen face and/or throat), dyspnea, throat tightness and chest pain/tightness - spontaneously reported in the post-marketing period.
Croatian: 6 Pojam „preosjetljivost” obuhvaća: anafilaksiju, angioedem (npr. otečeno lice i/ili grlo), dispneju,
English: Eluxadoline is an inhibitor of the hepatic uptake transporter OATP1B1.
Croatian: Eluksadolin je inhibitor prijenosnika jetrenog unosa OATP1B1.
English: Modified capsule-shaped, pink-orange to peach film-coated tablet of approximately 8 mm x 19 mm, debossed with “FX100” on one side.
Croatian: Filmom obložena tableta ružičasto-narančaste boje do boje breskve, modificiranog oblika kapsule dimenzija približno 8 mm x 19 mm, s utisnutom oznakom „FX100“ na jednoj strani.
English: In ESRD participants not yet on dialysis relative to matched, healthy participants with normal renal function, eluxadoline plasma Cmax was 2.2-fold higher and AUC0-t was 4.2-fold higher.
Croatian: Sudionici sa završim stadijem bolesti bubrega koji još nisu na dijalizi imali su Cmax plazme eluksadolina 2,2 puta veći, a AUC0-t 4,2 puta veći su u odnosu na njima odgovarajuće zdrave sudionike s normalnom funkcijom bubrega,.
English: Sphincter of Oddi spasm3
Croatian: spazam Oddijevog sfinktera3 pankreatitis
English: Gastric lavage or charcoal administration should be considered.
Croatian: Treba uzeti u obzir ispiranje želuca ili primjenu aktivnog ugljena.
English: Eluxadoline has a low potential for drug-drug interactions based on limited in vitro CYP inhibition/induction and given that eluxadoline is not a substrate for CYPs at clinically meaningful concentrations.
Croatian: CYP inhibicije/indukcije i s obzirom da eluksadolin nije supstrat za CYP-ove pri klinički značajnim koncentracijama.
English: Truberzi 75 mg film-coated tablets Each film-coated tablet contains 75 mg of eluxadoline.
Croatian: Truberzi 75 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 75 mg eluksadolina.
English: Adequate Relief Response
Croatian: Odgovor u pogledu odgovarajućeg ublažavanja
English: Silicified microcrystalline cellulose (E460); Colloidal anhydrous silica (E551);
Croatian: 6.1 Popis pomoćnih tvari silicifirana mikrokristalična celuloza (E460);
English: The plasma levels in patients with a genetic predisposition for poor function of OATP1B1 transporter are increased and in these patients a higher rate of adverse events, especially with regard to gastrointestinal events, as well as CNS effects might be expected (see section 4.4).
Croatian: OATP1B1 su povećane i u tih bolesnika se može očekivati viša stopa štetnih događaja, naročito što se tiče gastrointestinalnih događaja, kao i učinaka na središnji živčani sustav (vidjeti dio 5.2).
English: Modified capsule-shaped, pale yellow to light-tan film-coated tablet of approximately 7 mm x 17 mm, debossed with “FX75” on one side.
Croatian: Filmom obložena tableta blijedožute do svijetlosmeđe boje, modificiranog oblika kapsule dimenzija približno 7 mm x 17 mm, s utisnutom oznakom „FX75“ na jednoj strani.
English: Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this may increase the risk of constipation.
Croatian: Izbjegavajte čestu primjenu loperamida (lijek koji se koristi za liječenje proljeva) ako uzimate