natgillin/translations-raw huggingface dataset:
Core tablet: silicified microcrystalline cellulose (E460); colloidal anhydrous silica (E551); crospovidone, type B (E1202); mannitol (E421) and magnesium stearate (E572).
• jedro tablete: silicificirana mikrokristalna celuloza (E460), koloidni brezvodni silicijev dioksid (E551), krospovidon tipa B (E1202), manitol (E421) in magnezijev stearat (E572);
Each tablet contains 100 mg of eluxadoline.
Ena tableta vsebuje 100 mg eluksadolina.
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.
V obdobju trženja zdravila so poročali o resnih neželenih učinkih, kot je spazem Oddijevega sfinktra s pankreatitisom ali brez njega, zlasti pri bolnikih, ki nimajo žolčnika, zaradi česar so se morali zdraviti v bolnišnici.
Patients receiving eluxadoline reported significant increases in urgency-free days both for ≥50% urgency-free days as well as ≥75% urgency free days.
Pri bolnikih, ki so prejemali eluksadolin, so poročali o pomembnih povečanjih števila dni brez nujnega odvajanja blata pri merilih ≥ 50 % dni in ≥ 75 % dni brez nujnega odvajanja blata.
Co-administration of eluxadoline with probenecid (MRP2 inhibitor) resulted in approximately 1.4-fold increase in exposure to eluxadoline.
Sočasna uporaba eluksadolina s probenecidom (zaviralcem MRP2) je povzročila približno 1,4-kratno povečanje izpostavljenosti eluksadolinu.
5 “Rash" term includes: dermatitis, dermatitis allergic, rash, rash generalized, rash macula-papular, rash papular, rash pruritic, urticaria, and idiopathic urticarial.
5 Izraz »izpuščaj« vključuje: dermatitis, alergijski dermatitis, izpuščaj, generalizirani izpuščaj, makulopapulozni izpuščaj, papulozni izpuščaj, srbeč izpuščaj, urtikarijo in idiopatsko urtikarijo.
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.
2 % bolnikov, ki so prejemali 100 mg, v primerjavi z <1 % bolnikov, zdravljenih s placebom.
Although no direct drug-drug interactions have been demonstrated, chronic use of loperamide with eluxadoline should be avoided as this may increase the risk of constipation.
Zdravila, ki povzročajo zaprtost Čeprav niso dokazali nobenega neposrednega medsebojnega delovanja med zdravili, se kronična uporaba loperamida z eluksadolinom odsvetuje zaradi možnosti zvečanja tveganja za zaprtost.
These patients are at risk for significantly increased plasma concentrations of eluxadoline (see sections 4.4 and 5.2).
Ti bolniki so v nevarnosti za občutno zvišanje plazemskih koncentracij eluksadolina (glejte poglavji 4.4 in 5.2).
Abdominal Pain Response
Odziv bolečin v trebuhu
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.
27.100 l. Pri zdravih osebah se je eluksadolin zmerno (81 %) vezal na beljakovine v plazmi.
2“Abdominal pain" term includes: abdominal pain, abdominal pain lower, and abdominal pain upper.
2 Izraz »bolečine v trebuhu« vključuje: bolečine v trebuhu, bolečine v spodnjem delu trebuha in bolečine v zgornjem delu trebuha.
Other side effects can include
Drugi neželeni učinki so lahko:
Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this may increase the risk of constipation.
Izogibajte se pogosti uporabi loperamida (zdravilo za zdravljenje driske), če jemljete zdravilo
Each tablet contains 75 mg of eluxadoline.
Ena tableta vsebuje 75 mg eluksadolina.
Eluxadoline is a substrate of the hepatic efflux transporter MRP2.
Eluksadolin je substrat jetrnega izločevalnega prenašalca MRP2.
These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm (see section 4.4).
Ti bolniki imajo zvečano tveganje za pojav resnih neželenih učinkov pankreatitisa in/ali spazma Oddijevega sfinktra (glejte poglavje 4.4).
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj5
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.
Eluksadolin se izloča zlasti z blatom kot neabsorbirana zdravilna učinkovina ali prek žolčnega sistema, medtem ko imajo ledvice minimalno vlogo pri izločanju.
Patients with renal impairment No dose adjustment is necessary based on renal function (see sections 4.4 and 5.2).
Prilagajanje odmerka glede na delovanje ledvic ni potrebno (glejte poglavji 4.4 in 5.2).
No human data on the effect of eluxadoline on fertility are available.
O učinku eluksadolina na plodnost ni nobenih podatkov iz študij pri ljudeh.
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.
Izboljšanja globalnih simptomov IBS so bila ocenjena na podlagi opazovanega dogodka ustreznega odziva z olajšanjem simptomov, opredeljenega kot dosega ustreznega olajšanja simptomov IBS na vsaj 50 %
Placebo n=427
Place bo n=427
Truberzi should not be restarted in patients who developed biliary duct obstruction or sphincter of Oddi spasm while taking Truberzi (see section 4.3).
Zdravila Truberzi se ne sme ponovno uvesti pri bolnikih, pri katerih sta se med zdravljenjem z zdravilom Truberzi razvila zapora žolčevoda ali spazem Oddijevega sfinktra (glejte poglavje 4.3).
Film-coated tablets Multipack: 168 (3 packs of 56) tablets.
filmsko obložene tablete Veliko pakiranje: 168 tablet (3 pakiranja po 56).
The active substance has linear pharmacokinetics with no accumulation upon repeated twice daily dosing.
Med ponavljajočim se odmerjanjem dvakrat dnevno ima učinkovina linearno farmakokinetiko brez kopičenja.
Truberzi may decrease the level of some medicines in the blood.
Zdravilo Truberzi lahko zniža krvno koncentracijo nekaterih drugih zdravil.
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.
eden je bil povezan z nastankom oborin v žolčniku in v enem primeru je bolnik prekinil uporabo eluksadolina 2 tedna pred nastopom simptomov.
Eluxadoline is primarily cleared as such via the biliary system with the kidney playing a minimal role in elimination.
Eluksadolin se v glavnem izloča nespremenjen prek žolčnega sistema, medtem ko imajo ledvice minimalno vlogo pri izločanju.
Patients should be instructed to stop the medicinal product and seek medical attention if these symptoms develop while taking eluxadoline (see section 4.8).
Bolnikom je treba med jemanjem eluksadolina naročiti, naj v primeru pojava teh simptomov zdravilo prenehajo jemati in poiščejo zdravniško pomoč (glejte poglavje 4.8).
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.
Pri udeležencih s končno fazo ledvične odpovedi (ESRD - End Stage Renal Disease), ki se še ne zdravijo z dializo, se je izpostavljenost eluksadolinu bistveno povečala v primerjavi z ujemajočimi se,
Sphincter of Oddi spasm3
spazem Oddijevega sfinktra3 pankreatitis
Pharmacokinetic data for healthy volunteers pooled across Phase 1 studies (using the 100 mg single oral dose) and analyzed for potential differences based on sex, age, race, and BMI demonstrated no significant differences.
(z uporabo posameznega peroralnega odmerka 100 mg) ter analizirani glede morebitnih razlik glede na spol, starost, raso in ITM, niso pokazali pomembnih razlik.
The binding affinity (Ki) of eluxadoline for human κOR has not been determined; however, the Ki for guinea pig cerebellum κOR is 55 nM.
Afiniteta za vezavo (Ki) eluksadolina na humane receptorje μOR in δOR je 1,8 nM oziroma 430 nM. Afiniteta za vezavo (Ki) eluksadolina na humane receptorje κOR ni ugotovljena; vendar je Ki za κOR v malih možganih morskih prašičkov 55 nM.
The efficacy and safety of eluxadoline in IBS-D patients was established in two randomized, multicenter, multi-national, double-blind, placebo-controlled studies (Studies 1 & 2).
multicentričnih, multinacionalnih, dvojno slepih, s placebom nadzorovanih študijah (študiji 1 in 2).
These patients are at increased risk for sphincter of Oddi spasm (see section 4.4).
Ti bolniki imajo zvečano tveganje za spazem Oddijevega sfinktra (glejte poglavje 4.4).
These medicines can include: - erythromycin (used to treat infections); - midazolam (a medicine to sedate you when you e.g. undergo endoscopic procedures); - nifedipine (used to treat high blood pressure); - alfentanil, fentanyl (opioid analgesic used to treat pain); - dihydroergotamine, ergotamine (used to treat migraine); - pimozide (used to treat mental disorders); - quinidine (used to treat heart diseases); - sirolimus, tacrolimus (immunosuppressant used for the control of body's immune response).
Med temi zdravili so lahko: - eritromicin (uporablja se za zdravljenje okužb); - midazolam (zdravilo za pomiranje, ga prejmete npr. med opravljanjem endoskopskih preiskav); - nifedipin (uporablja se za zdravljenje visokega krvnega tlaka); - alfentanil, fentanil (opioidna analgetika, ki se uporabljata za lajšanje bolečin); - dihidroergotamin, ergotamin (zdravila za zdravljenje migrene); - pimozid (uporablja se za zdravljenje duševnih bolezni); - kinidin (uporablja se za zdravljenje bolezni srca); - sirolimus, takrolimus (imunosupresiva, ki se uporabljata za nadzor imunskega odziva telesa).
The apparent clearance of eluxadoline is markedly reduced and half-life increases in hepatic-impaired patients (see sections 4.3 and 4.4).
Pri bolnikih z okvaro jeter je navidezni očistek eluksadolina izrazito zmanjšan in razpolovni čas podaljšan (glejte poglavji 4.3 in 4.4).
The recommended dose is 200 mg daily (one 100 mg tablet, twice daily).
Priporočeni odmerek je 200 mg dnevno (po ena 100 mg tableta dvakrat dnevno).
Eluxadoline may cause constipation.
Eluksadolin lahko povzroči zaprtost.
Pack sizes of 28, 56 and a multipack containing 168 (3 packs of 56) film-coated tablets.
Pakiranja po 28,56 ter velika pakiranja s 168 (3 pakiranja po 56) filmsko obloženih tablet.
Truberzi 100 mg film-coated tablets Each film-coated tablet contains 100 mg of eluxadoline.
Truberzi 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg eluksadolina.
Gastrointestinal disorders
dispepsijo in gastritis.
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).
Po enkratnem peroralnem odmerku 100 mg pri osebah z različnimi stopnjami okvare jeter in pri zdravih osebah so bile plazemske koncentracije eluksadolina v povprečju za 6-krat, 4-krat in 16-krat povišane pri osebah z blago, zmerno in hudo okvaro jeter
Modified capsule-shaped, pale yellow to light-tan film-coated tablet of approximately 7 mm x 17 mm, debossed with “FX75” on one side.
Filmsko obložene tablete bledo rumene do svetlo rjave barve, v obliki modificirane kapsule, velike približno 7 mm x 17 mm in z vtisnjeno oznako »FX75« na eni strani.
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.
6 Izraz »preobčutljivost« vključuje: anafilaksijo, angioedem (npr. zatekel obraz in/ali grlo), dispnejo,
OATP1B1 inhibitors
Zaviralci OATP1B1
Name and address of the manufacturer responsible for batch release
A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
Truberzi 75 mg film-coated tablets Each film-coated tablet contains 75 mg of eluxadoline.
Truberzi 75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg eluksadolina.
Eluxadoline is a substrate of the hepatic uptake transporter OATP1B1.
Eluksadolin je substrat jetrnega privzemnega prenašalca OATP1B1.
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.
Pri udeležencih s končno fazo ledvične odpovedi (ESRD), ki se še niso zdravili z dializo, je bila vrednost plazemske koncentracije eluksadolina Cmax 2,2-krat in vrednost AUC0-t 4,2-krat višja v primerjavi z ujemajočimi se, zdravimi udeleženci.
Modified capsule-shaped, pink-orange to peach film-coated tablet of approximately 8 mm x 19 mm, debossed with “FX100” on one side.
Filmsko obložene tablete rožnato oranžne do breskove barve, v obliki modificirane kapsule, velike približno 8 mm x 19 mm in z vtisnjeno oznako »FX100« na eni strani.
Eluxadoline is an inhibitor of the hepatic uptake transporter OATP1B1.
Eluksadolin je zaviralec jetrnega privzemnega prenašalca OATP1B1.
Truberzi may increase the level of some medicines in the blood.
Zdravilo Truberzi lahko zviša krvno koncentracijo nekaterih drugih zdravil.
EU/1/16/1126/001 56 film-coated tablets EU/1/16/1126/002 28 film-coated tablets
EU/1/16/1126/001 56 filmsko obloženih tablet EU/1/16/1126/002 28 filmsko obloženih tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 100 mg
PODATKI NA ZUNANJI OVOJNINI škatla - 100 mg
EU/1/16/1126/003 56 film-coated tablets EU/1/16/1126/004 28 film-coated tablets
EU/1/16/1126/003 56 filmsko obloženih tablet EU/1/16/1126/004 28 filmsko obloženih tablet
Truberzi 100 mg film-coated tablets
Truberzi 100 mg filmsko obložene tablete
How to store Truberzi
Shranjevanje zdravila Truberzi
Severe constipation that can lead to hospitalization has happened after taking Truberzi.
Po jemanju zdravila Truberzi je prišlo do hudega zaprtja, ki lahko vodi v hospitalizacijo.
No dose adjustment is necessary for co-administered OATP1B1 substrates.
Pri sočasni uporabi substratov OATP1B1 ni treba prilagoditi odmerkov.
Co-administration of eluxadoline with cyclosporine (an OATP1B1 inhibitor) increased eluxadoline exposure by approximately 5-fold (see sections 4.3 and 4.5).
Pri sočasni uporabi eluksadolina s ciklosporinom (zaviralcem OATP1B1) se je izpostavljenost eluksadolinu povečala za približno 5-krat
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.
Odkrili so samo en manjši in neaktiven presnovek eluksadolina acilglukuronidni presnovek (M11), ki nastane z glukuronidacijo skupine metoksibenzojske kisline.
Nervous system disorders
Bolezni živčevja omotica zaspanost1
- if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6); - if you have, or have had, pancreatitis (inflammation of the pancreas); - if you don't have a gallbladder by birth or your gallbladder has been surgically removed; - if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink alcohol; - if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum); - if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine);
- če imate ali ste imeli kakršnokoli zaporo v žolčniku, žolčevodu ali trebušni slinavki (kot so žolčni kamni, tumor, divertikel dvanajstnika); - če imate ali ste imeli bolezen ali nepravilno delovanje Oddijevega sfinktra (majhna krožna mišica v zgornjem delu trebuha, ki nadzira pretok žolča in sokov trebušne slinavke v zgornji del črevesja);
Truberzi 75 mg film-coated tablets
Truberzi 75 mg filmsko obložene tablete
Truberzi should not be taken whilst pregnant or breast-feeding.
Nosečnice ali doječe matere ne smejo jemati zdravila Truberzi.
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).
OATP1B1 so zvišane in pri teh bolnikih se lahko pričakuje več neželenih učinkov, zlasti učinkov na prebavila in osrednje živčevje (glejte poglavje 4.4).
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.
OATP1B1, substrat jetrnega izločevalnega prenašalca MRP2 in ni substrat ali zaviralec prenašalcev
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).
Spazem Oddijevega sfinktra Zaradi agonističnega delovanja eluksadolina na opioidne receptorje mi lahko imajo bolniki, ki jemljejo eluksadolin, zlasti tisti brez žolčnika, večje tveganje za spazem Oddijevega sfinktra s posledičnim pankreatitisom ali zvišanimi vrednostmi jetrnih encimov in spremljajočo akutno bolečino v trebuhu
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 75 mg
PODATKI NA ZUNANJI OVOJNINI škatla - 75 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 75 mg
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OZNAČBA (Z MODRIM OKENCEM - SAMO VELIKO PAKIRANJE) - 75 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 100 mg
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OZNAČBA (Z MODRIM OKENCEM - SAMO VELIKO PAKIRANJE) - 100 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 75 mg
NOTRANJA ŠKATLA (BREZ MODREGA OKENCA - SAMO VELIKO PAKIRANJE)75 mg
- severe constipation.
- občutek napihnjenosti;
- The active substance is eluxadoline.
- Učinkovina je eluksadolin.
The film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with ‘FX75' on one side.
Filmsko obložene tablete so bledo rumene do svetlo rjave barve, v obliki modificirane kapsule, z vtisnjeno oznako »FX75« na eni strani.
- if you have, or have had, disease or dysfunction of the sphincter of Oddi (a small round muscle in your upper belly that controls the flow of bile and pancreatic fluids into your upper intestine); - if you have liver disease with decreased liver function; - if you have had constipation for a while or if constipation is the main symptom of your IBS
- če imate bolezen jeter z zmanjšanim delovanjem jeter; - če ste bili dalj časa zaprti ali če je zaprtost glavni simptom vašega sindroma razdražljivega črevesa (kar se imenuje »sindrom razdražljivega črevesa z zaprtostjo« [IBS-C]); - če imate ali obstaja možnost, da imate zaporo v črevesju; - če jemljete zdravila, ki lahko povečajo raven koncentracije eluksadolina v krvi (t. i. zaviralci
EU/1/16/1126/006 168 film-coated tablets (3 packs of 56)
EU/1/16/1126/006 168 filmsko obloženih tablet (3 pakiranja po 56)
The absorption of eluxadoline was rapid under fasting conditions, with a median Tmax value of 2 hours.
s srednjo vrednostjo Tmax 2 uri.
EU/1/16/1126/005 168 film-coated tablets (3 packs of 56)
EU/1/16/1126/005 168 filmsko obloženih tablet (3 pakiranja po 56)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 100 mg
NOTRANJA ŠKATLA (BREZ MODREGA OKENCA - SAMO VELIKO PAKIRANJE)100 mg
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.
Če se med jemanjem zdravila Truberzi pojavi ali poslabša bolečina v trebuhu, s siljenjem na bruhanje in bruhanjem ali brez njiju, prenehajte jemati zdravilo Truberzi in takoj poiščite zdravniško pomoč.
Adequate Relief Response
Odziv z ustreznim olajšanjem simptomov
Sphincter of Oddi spasm
Spazem Oddijevega sfinktra
The film-coated tablets are modified capsule-shaped, pink-orange to peach and debossed with ‘FX100' on one side.
Filmsko obložene tablete so rožnato oranžne do breskove barve, v obliki modificirane kapsule, z vtisnjeno oznako »FX100« na eni strani.
• Known or suspected biliary tree and/or pancreatic duct obstruction (e.g. gallstones, tumour, periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction.
tumor, periampularni duodenalni divertikel) ali bolezen ali nepravilno delovanje Oddijevega sfinktra.
Effect of OATP1B1 transporter function variability on plasma levels 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 5.2).
OATP1B1 so zvišane in pri teh bolnikih se lahko pričakuje več neželenih učinkov, zlasti učinkov na prebavila in osrednje živčevje (glejte poglavje 5.2).
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.
Pogostnost hude zaprtosti pri bolnikih, ki so prejemali 75 mg in 100 mg eluksadolina, je bila manj kot
Iron oxide red (E172).
smukec (E553b), rumeni železov oksid (E172), rdeči železov oksid (E172).
Film-coated tablets 56 tablets.
56 tablet.
There is an increased risk of pancreatitis with or without sphincter of Oddi spasm (see section 4.3) in patients taking eluxadoline.
Pri bolnikih, ki jemljejo eluksadolin obstaja zvečano tveganje za pankreatitis s spazmom Oddijevega sfinktra ali brez (glejte poglavje 4.3).
Therefore, in this population, the 75 mg dose twice daily can be used.
Zato se pri tej populaciji lahko uporablja odmerek 75 mg dvakrat dnevno (glejte poglavji 4.2 in 4.4).
Polyvinyl alcohol (E1203);
• filmska obloga: polivinilalkohol (E1203), titanov dioksid (E171), makrogol 3350
Gastric lavage or charcoal administration should be considered.
Razmisliti je treba o izpiranju želodca ali dajanju aktivnega oglja.
Caution should be exercised when administering eluxadoline in IBS patients whose bowel habits vary over time.
Pri bolnikih s sindromom razdražljivega črevesa, pri katerih se vzorec odvajanja blata spreminja skozi čas, je treba eluksadolin uporabljati previdno.
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.
Pri bolnikih, ki imajo zvišane plazemske koncentracije, kot so bolniki z gensko nagnjenostjo k slabemu delovanju prenašalca OATP1B1, je tveganje za zaspanost in sedacijo med zdravljenjem z eluksadolinom lahko povečano (glejte poglavje 4.8).
- if you are allergic to eluxadoline or any of the other ingredients of this medicine (listed in section 6); - if you have, or have had, pancreatitis (inflammation of the pancreas); - if you don't have a gallbladder by birth or your gallbladder has been surgically removed; - if you have, or have had, problems with alcohol abuse, alcohol addiction, or if you drink alcohol; - if you have, or have had, any blockage in your gallbladder, bile ducts, or pancreas (such as gallstones, tumour, duodenal diverticulum);
- če ste alergični na eluksadolin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate ali ste imeli pankreatitis (vnetje trebušne slinavke);
0.5 ml (10 µg/ml) 1 vial + 1 syringe + 1 needle
1 viala + 1 injekcijska brizga + 1 igla