natgillin/translations-raw huggingface dataset:
There is an increased risk of pancreatitis with or without sphincter of Oddi spasm (see section 4.3) in patients taking eluxadoline.
Postoji povećani rizik od pankreatitisa sa ili bez spazma Oddijevog sfinktera (vidjeti dio 4.3) u bolesnika koji uzimaju eluksadolin.
Do not use this medicine after the expiry date which is stated on blister and the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake 'Rok valjanosti'.
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.
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.
Given eluxadoline's action at opioid receptors, administration of a narcotic mu opioid antagonist, such as naloxone, should be considered.
S obzirom na to da eluksadolin djeluje na opioidne receptore, treba uzeti u obzir primjenu narkotičkog antagonista mi opioidnih receptora, kao što je nalokson.
Patients should be instructed to stop the medicinal product and seek medical attention if these symptoms develop while taking eluxadoline (see section 4.8).
Bolesnike treba savjetovati da prekinu uzimati lijek i potraže liječničku pomoć ako se ti simptomi razviju dok uzimaju eluksadolin (vidjeti dio 4.8).
Film-coating: polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol 3350 (E1521); talc (E553b); iron oxide yellow (E172) and iron oxide red (E172).
Film-ovojnica: poli(vinilni alkohol) (E1203); titanijev dioksid (E171); makrogol 3350 (E1521); talk (E553b); žuti željezov oksid (E172) i crveni željezov oksid (E172).
It is unknown whether eluxadoline is excreted in human milk.
Nije poznato izlučuje li se eluksadolin u majčino mlijeko.
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.
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.
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).
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).
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).
Istodobna primjena inhibitora OATP1B1 (ciklosporin, gemfibrozil, antiretrovirotici [atazanavir, lopinavir, ritonavir, sakvinavir, tipranavir], rifampicin) s eluksadolinom može povećati izloženost eluksadolinu (vidjeti dio 5.2).
Eluxadoline is a locally acting, mixed mu opioid receptor (μOR) agonist and delta opioid receptor
Eluksadolin je lokalno djelujući, miješani agonist mi-opioidnih receptora (μOR) i antagonist deltaopioidnih receptora (δOR).
MRP2 inhibitors
Inhibitori MRP2
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.
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.
Patients should be instructed to stop the medicinal product and seek medical attention if they develop severe constipation (see section 4.4).
Bolesnike treba uputiti da prekinu uzimati lijek i potraže medicinsku pomoć ako se javi teška konstipacija (vidjeti dio 4.4).
All events of sphincter of Oddi spasm occurred in patients without a gallbladder.
Svi događaji spazma Oddijevog sfinktera nastupili su u bolesnika koji nisu imali žučni mjehur.
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).
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).
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.
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.
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).
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).
The use of eluxadoline with other medicinal products that may cause constipation (for example anticholinergics, opioids etc) should also be avoided.
Treba također izbjegavati primjenu eluksadolina s drugim lijekovima koji mogu izazvati konstipaciju (na primjer antikolinergici, opioidi i sl.).
• Patients on treatment with potent inhibitors of OATP1B1 (e.g. cyclosporine)
• Bolesnici koji se liječe potentnim inhibitorima OATP1B1 (npr. ciklosporin).
During the 4 week single-blind withdrawal period in Study 2 (IBS-3002), no evidence of rebound diarrhoea or abdominal pain was demonstrated.
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.
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.
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.
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.
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.
Film-coated tablets Multipack: 168 (3 packs of 56) tablets.
Filmom obložene tablete Višestruko pakiranje: 168 (3 pakiranja od 56) tableta.
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.
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.
Core tablet: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); crospovidone, type B (E1202); mannitol (E421) and magnesium stearate (E572).
Jezgra tablete: silicifirana mikrokristalična celuloza (E460); koloidni, bezvodni silicijev dioksid (E551); krospovidon, tip B (E1202); manitol (E421) i magnezijev stearat (E572).
Hepatic impairment or coadministration with cysclosporine results in significant increases in plasma concentrations of eluxadoline.
Oštećenje funkcije jetre ili istodobna primjena sa ciklosporinom rezultira značajnim povećanjima koncentracije eluksadolina u plazmi.
Study 2 (IBS-3002) included a 4-week single-blinded, placebo-withdrawal period upon completion of the 26-week treatment period.
Ispitivanje 2 (IBS-3002) obuhvaćalo je 4-tjedno jednostruko slijepo razdoblje ustezanja od lijeka uz primjenu placeba nakon dovršetka razdoblja liječenja od 26 tjedana.
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.
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.
Eluxadoline has a minor influence on the ability to drive and use machines.
Eluksadolin malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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).
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).
Film-coated tablets 56 tablets.
Filmom obložene tablete 56 tableta.
Abdominal Pain Response
Odgovor u pogledu boli u abdomenu
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).
Truberzi u jednoj ili više podskupina pedijatrijske populacije s dijagnozom IBS-D-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
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).
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).
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.
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).
A relevant proportion of patients diagnosed with IBS-D may be affected by bile-acid malabsorption as a potential reason for IBS-D symptoms.
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.
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.
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.
Eluxadoline's systemic exposure following oral administration is low and is consistent with its local action in the GI tract.
Sistemska izloženost eluksadolinu nakon peroralne primjene je niska i u skladu s lokalnim djelovanjem u GI traktu.
Co-administration of eluxadoline with probenecid (MRP2 inhibitor) resulted in approximately 1.4-fold increase in exposure to eluxadoline.
Istodobna primjena eluksadolina s probenecidom (inhibitorom MRP2) rezultirala je porastom za približno 1,4 puta u izloženosti eluksadolinu.
Caution should be exercised when administering eluxadoline in IBS patients whose bowel habits vary over time.
Potreban je oprez prilikom primjene eluksadolina u bolesnika s IBS-om čiji se ritam pražnjenja crijeva mijenja tijekom vremena.
• A history of pancreatitis; or known or suspected structural diseases of the pancreas, including pancreatic duct obstruction.
• Pankreatitis u anamnezi, ili utvrđene ili suspektne strukturne bolesti gušterače, uključujući opstrukciju gušteračnog voda.
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.
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.
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.
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.
BSS <5 Response
Odgovor u pogledu BSS-a
In both studies, the proportion of patients who were composite responders to Truberzi 100 mg twice daily was statistically significantly higher than placebo.
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.
Pack sizes of 28, 56 and a multipack containing 168 (3 packs of 56) film-coated tablets.
Veličine pakiranja od 28, 56 te višestruko pakiranje koje sadrži 168 (3 pakiranja od 56) filmom obloženih tableta.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - 100 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - 100 mg
All patients met Rome III criteria for IBS and were required to meet the following criteria:
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
These patients are at risk for significantly increased plasma concentrations of eluxadoline (see sections 4.4 and 5.2).
U tih bolesnika postoji rizik od značajno povećanih koncentracija eluksadolina u plazmi (vidjeti dijelove 4.4 i 5.2).
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.
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.
Stop taking Truberzi and call your doctor right away if you develop severe constipation while taking Truberzi.
Prestanite uzimati Truberzi i odmah se javite svom liječniku ako imate teški oblik zatvora dok uzimate Truberzi.
There is limited amount of data from the use of eluxadoline in pregnant women.
Podaci o primjeni eluksadolina u trudnica su ograničeni.
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.
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.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - 75 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - 75 mg
Eluxadoline may cause constipation.
Eluksadolin može uzrokovati konstipaciju.
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.
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.
Each tablet contains 100 mg of eluxadoline.
Jedna tableta sadrži 100 mg eluksadolina.
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).
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
It is used to treat irritable bowel syndrome (‘IBS') with diarrhoea (IBS-D) in adults.
Koristi se za liječenje sindroma iritabilnog crijeva (IBS) s proljevom (engl. irritable bowel syndrome with diarrhoea, IBS-D) u odraslih.
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).
- 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);
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.
Biotransformacija Eluksadolin se prvenstveno izlučuje putem fecesa, bilo kao neapsorbirana djelatna tvar ili putem bilijarnog sustava, pri čemu bubreg ima minimalnu ulogu u eliminaciji.
Eluxadoline is primarily cleared as such via the biliary system with the kidney playing a minimal role in elimination.
Eluksadolin se prvenstveno uklanja neizmijenjen putem bilijarnog sustava, pri čemu bubreg ima minimalnu ulogu u eliminaciji.
Keep this medicine out of the sight and reach of children.
Kako čuvati Truberzi Lijek čuvajte izvan pogleda i dohvata djece.
2“Abdominal pain" term includes: abdominal pain, abdominal pain lower, and abdominal pain upper.
2 Pojam „bol u abdomenu“ obuhvaća: bol u abdomenu, bol u donjem dijelu abdomena i bol u gornjem dijelu abdomena.
Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D).
Truberzi je indiciran u odraslih za liječenje sindroma iritabilnog crijeva s proljevom (engl. irritable bowel syndrome with diarrhoea, IBS-D).
Unchanged eluxadoline recovered in urine was 0.01% and 0.05% of dose in ESRD and healthy participants, respectively.
Nepromijenjeni eluksadolin izlučen u mokraći iznosio je 0,01 % odnosno 0,05 % doze primijenjene u sudionika sa završnim stadijem bolesti bubrega odnosno zdravih sudionika.
5 “Rash" term includes: dermatitis, dermatitis allergic, rash, rash generalized, rash macula-papular, rash papular, rash pruritic, urticaria, and idiopathic urticarial.
5 Pojam „osip“ obuhvaća: dermatitis, alergijski dermatitis, osip, generalizirani osip, makulopapularni osip, papularni osip, pruritični osip, urtikariju i idiopatsku urtikariju.
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.
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.
(see section 4.5).
(vidjeti dio 4.8).
Patients with renal impairment No dose adjustment is necessary based on renal function (see sections 4.4 and 5.2).
Nije potrebno prilagođavati dozu prema bubrežnoj funkciji (vidjeti dijelove 4.4 i 5.2).
• 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.
24 sata od >3,0 na ljestvici od 0 do 10 tijekom tjedna prije randomizacije.
The efficacy results for ≥50% of responder days (primary composite endpoint) over 6 months are shown in Table 2.
Rezultati djelotvornosti za ≥50% dana s odgovorom na liječenje (primarni kompozitni ishod) tijekom
Eluxadoline is not an inducer/inhibitor of major CYP enzymes, however, eluxadoline has some potential for the metabolism based inactivation of CYP3A4.
Eluksadolin ne djeluje kao induktor/inhibitor glavnih enzima CYP, međutim, eluksadolin ima određene mogućnosti inaktivacije
The apparent clearance of eluxadoline is markedly reduced and half-life increases in hepatic-impaired patients (see sections 4.3 and 4.4).
Prividni klirens eluksadolina značajno je smanjen, a poluvijek se povećava u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.3 i 4.4).
These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm (see section 4.4).
U tih je bolesnika povećan rizik od nastanka ozbiljnih nuspojava pankreatitisa i/ili spazma Oddijevog sfinktera (vidjeti dio 4.4).
Each tablet contains 75 mg of eluxadoline.
Jedna tableta sadrži 75 mg eluksadolina.
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).
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
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).
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).
No dose adjustment is necessary for co-administered OATP1B1 substrates.
Nije potrebno prilagođavati dozu za istodobno primijenjene supstrate OATP1B1.
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.
smatralo se da su nepotrebna prospektivna klinička ispitivanja u vezi razlika u dobi, indeksu tjelesne mase (ITM), etničkog podrijetla i spola.